Ortho-Clinical Diagnostics recalls

• Sept. 24, 2025Chemistry Products LAC Slides… and 1 more product Class IIVITROS Chemistry Products LAC Slides on VITROS XT 3400 and VITROS XT 7600 Systems are experiencing an increased occurrence of calibration failure…
• Aug. 27, 2025VITROS Chemistry Products Ca Slides… Class IIGenerations 67 and above of VITROS Ca Slides are experiencing an increased occurrence of Condition Code TH4-63J during calibration on VITROS XT 3400…
• July 23, 2025Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry… and 3 more products Class IIQuality control (QC) drift when certain lots of Performance Verifiers (PVs) are used with certain lots of cholinesterase enzyme (CHE) slides. This…
• July 9, 2025VITROS Chemistry Products OP Reagent Gen 15… Class IILots from Generation (GEN) 15 of VITROS Chemistry Products OP Reagent may generate lower than expected quality control (QC) results. If the customer…
• July 9, 2025Brand Name: VITROS Product Name: VITROS 5600 Integrated System… and 2 more products Class IIA software anomaly allows test results to be reported using Micro Tip and Micro Slide diluent packs that the system treats as expired even when the…
• June 18, 2025Brand Name: Solana¿ Bordetella Complete Assay Product Name: Solana Bordetella kit Model/Catalog Number: M308… Class IIIt was determined that there could be a false positive rate of up to 16.7% for the affected lots associated with the Bordetella parapertussis (BPP)…
• June 4, 2025VITROS Chemistry Products CRP Slides… Class IIProduct was incorrectly assigned GEN 88 instead of GEN 83 on product carton, foil wrapper, and cartridge (cart) label.
• Jan. 29, 2025Brand Name: VITROS Product Name: VITROS 5600 Integrated System… and 2 more products Class IIThe VITROS 5600 Integrated System software versions 3.8.0 may not correctly notify users if the Signal Reagent Pack exceeds the on-board and/or…
• Dec. 4, 2024VITROS Chemistry Products CRP Slides- In vitro diagnostic quantitatively measures C-reactive protein (CRP)… Class IIMay Generate Negatively Biased Results When Testing Samples with High Concentrations of CRP, showing less than upper AMI of 90 mg/L (in the 70-90…
• Aug. 28, 2024The VITROS XT Chemistry Products ALB-TP Slides is a single device that contains both an albumin test and a… Class IIThe reason for this recall is QuidelOrtho has determined that during normal use the VITROS XT ALB-TP Slides may shed dust and debris as they travel…
• Aug. 21, 2024VITROS Immunodiagnostic VITROS Folate Reagent Pack 1/2 Class IIIt was confirmed that fibrinogen in patient plasma samples precipitates out of solution upon the addition of folate stabilizer reagent as part of the…
• July 10, 2024VITROS Chemistry Products FS Diluent Pack 3… Class IIVITROS Chemistry Products FS Diluent Pack 3, Lot 01-1645 may cause results to be negatively biased when used to dilute patient samples tested with…
• July 10, 2024VITROS Chemistry Products Calibrator Kit 29- In-Vitor used to calibrate the VITROS 5,1 FS/4600 Chemistry… Class IIIKit assigned an extended expiration date of 24-Jul-2025 during release. The correct expiration date for Lot 2953 is 24-Jul-2024. If used past its…
• June 19, 2024VITROS Immunodiagnostic Products Anti HBs Calibrators… Class IIPotential for positively biased results due to signal reduction over shelf life.
• June 12, 2024VITROS Immunodiagnostic Products Vitamin B12 Range Verifier… Class IIIThe results generated by the VITROS Immunodiagnostic Products Vitamin B12 Range Verifier Lot# 1200 RV Level 2 may cause range verification failure.…
• April 3, 2024VITROS Performance Verifier I and 1 more product Class IIThe issue was mismatched diluent lots assembled into VITRO Chemistry Products Performance Verifier I and II. This issue has the potential to cause…
• March 13, 2024VITROS 3600 Immunodiagnostic System Catalog Nos… and 4 more products Class IIA software defect affecting VITROS Systems running VITROS Software Versions 3.8.0 and 3.8.1 causes the Configurable Westgard Rules to not report as…
• March 13, 2024VITROS 3600 Immunodiagnostic System Catalog Nos… and 4 more products Class IIA software defect affecting VITROS Systems running VITROS Software Versions 3.8.1 causes QC baseline statistics to not update as expected when…
• March 13, 2024VITROS 3600 Immunodiagnostic System (New and Refurbished) and 2 more products Class IIPotential For Aspiration from Unintended Sample Container During Sampling Center Processing on VITROS¿ 3600 Immunodiagnostic Systems and VITROS¿…
• Jan. 31, 2024VITROS Immunodiagnostic Products Anti-HBs Quantitative Reagent Pack… Class IIAffected lots may experience increased calibration failures or an increase in falsely elevated results.
• Jan. 17, 2024QMS Tacrolimus Calibrators… Class IIOrtho-Clinical Diagnostics, Inc. is recalling QMS Tacrolimus Calibrators, Lot 74859619 expiry date: May 11, 2024, due to improper storage that is…
• Dec. 20, 2023VITROS 3600 Immunodiagnostic System Product Code 6802783 and… and 4 more products Class IIDuring planned monitoring of data post-release of Software Version 3.8.0 an increased occurrence of software issues relating to unresponsive…
• Dec. 13, 2023VITROS Chemistry Products ECO2 Slides-For in vitro diagnostic use only… Class IIOrtho Clinical Diagnostics (QuidelOrtho) confirmed during routine testing that some lots from Coating 3598 of VITROS ECO2 slides included carts which…
• Nov. 15, 2023VITROS Chemistry Products Lipase Slides… Class IIProducts 1668409 and 8297749 may contain VITROS Lipase Slides with an abnormality which could cause -46% to +86% bias in lipase results depending on…
• Oct. 11, 2023Proboscis/Piston Assembly… Class IIOrtho Clinical Diagnostics (QuidelOrtho) confirmed certain Proboscis/Piston Assemblies manufactured between 07-Apr-2022 (Date code: 040722) and…
• Sept. 27, 2023VITROS XT Chemistry Products TBIL-ALKP Slides and 1 more product Class IISamples containing high levels of ALKP (or an interfering substance) could deplete the available substrate in the reagent layer of a VITROS ALKP…
• Aug. 16, 2023VITROS Immunodiagnostic Products Troponin I ES Reagent Pack and 1 more product Class IIReagent packs could potentially contain incorrect wells, which will generate incorrect, and potentially false negative, results.
• Aug. 2, 2023VITROS Immunodiagnostic Products NT-proBNP II Range Verifiers-For in vitro diagnostic use only… Class IIIMay not meet the stability specifications for shelf life outlined in the Instructions For Use (IFU).
• July 19, 2023VITROS Chemistry Products Calibrator Kit 20-in vitro diagnostic use only… Class IIPotential to cause biased results in the upper end of the reportable range for the quantitative measurement of Transferrin, C3, C4, IgA, IgG and IgM.…
• June 7, 2023VITROS Chemistry Products Calibrator Kit 11 VANC Reagent Generation (GEN) 50 with affected Assay Data Disk… Class IIUnavailable to calibrate VITROS Chemistry Products VANC Reagent, Generation (GEN) 50, results in delay of testing
• May 31, 2023VITROS Chemistry Products HbA1c Reagent Kit- IVD for the quantitative determination of percent glycated… Class IIPotential for both unexpected positive and negative HbA1c results, may result in misdiagnosis
• May 10, 2023VITROS XT 7600 Integrated System… and 2 more products Class IIMicroTip Pack Opener Assembly Potentially Not Removing or Replacing MicroTip Pack Caps on VITROS¿ 5600 and XT 7600 Integrated Systems, results may be…
• April 26, 2023VITROS Immunodiagnostic Products Anti-SARSCoV- 2 Total N Antibody Calibrators programmed onto the Assay Data… Class IIIncorrect Number of Calibrator Levels (2) Set for the VITROS Immunodiagnostics Products Anti-SARS-CoV-2 Total N Antibody Calibrators in Assay Data…
• Jan. 11, 2023VITROS Immunodiagnostic Products Intact PTH Reagent Pack- IVD For the quantitative measurement of intact… Class IILower than expected iPTH patient and Quality Control (QC) results, reported negatively biased iPTH results- an average -12% shift in patient sample…
• Nov. 16, 2022VITROS Chemistry Products Calibrator Kit 9 -(GEN) 22 of VITROS PHYT Slides For in vitro diagnostic use only… Class IICalibration disk Data Release Version (DRV) 6194 to 6200 contain inappropriate calibration mathematics for VITROS Calibration Kit 9 for calibrating…
• Sept. 14, 2022VITROS XT 3400 Chemistry System with Version 3.7.2 and below Product… and 1 more product Class IIPerforming a system shutdown on VITROS XT 3400 and VITROS XT 7600 Systems may cause a positive or negative shift in the electrical current supplied…
• July 20, 2022Anti-SARS-CoV-2 IgG Quantitative Reagent Pack- Intended for use on VITROS¿ ECi/ECiQ/3600 Immunodiagnostic… Class IIOn-Analyzer Stability (OAS) time, supported for 6 weeks; not 8 weeks as is currently stated in the Instructions For Use (IFU).
• May 25, 2022VITROS Immunodiagnostic Products FSH Reagent Pack- IVD 1931922 and 2 more products Class IIFalsely high or delayed patient and QC results may occur due to low end imprecision. VITROS Immunodiagnostic Products FSH, LH and Prol Reagents Low…
• March 16, 2022VITROS Chemistry Products VersaTips… Class IIThe lot has a shape deformity which may lead to a 16% reduction in the volume of the sample or reagent dispensed. In cases where the error is not…
• Jan. 26, 2022VITROS Immunodiagnostic Products High Sample Diluent A Reagent Pack Class IILower than expected results for VITROS¿ Immunodiagnostic Products TSH Reagent Pack when diluted with VITROS¿ Immunodiagnostic Products High Sample…
• Nov. 24, 2021VITROS Immunodiagnostic Products Anti-HBc IgM Controls… Class IIIOrtho Clinical Diagnostics confirmed a complaint that some VITROS Immunodiagnostic Products Anti-HBc IgM Controls Lot 1690 Controls Values booklet…
• Oct. 27, 2021VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Quantitative Controls (IVD)- For use in monitoring the… Class IIVITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Quantitative Controls Outside of Expected Control Range, potential for delayed results
• June 2, 2021VITROS CoV2 Ag calibrator (Product Code 6199950)… Class IIOrtho investigated and confirmed the potential for unexpected failed calibration, and condition codes associated with the calibration, when using…
• May 5, 2021VITROS¿ Black Reference Slides CATALOG #: J02316… Class IIDelayed results. Ortho confirmed that two lots of VITROS Black Reference Slides are incorrectly labelled as White Reference Slides. If the customer…
• March 31, 2021VITROS Chemistry Products Calibrator Kit 4-(Calibrator values for TIBC only)… Class IIPotential total iron-binding capacity (TIBC) results. The VITROS TIBC performance shift will start with the newest Generation (GEN) of VITROS Fe…
• March 24, 2021VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Reagent- In Vitro… and 1 more product Class IIVITROS Immunodiagnostic Products SARS-CoV-2 Antigen False Reactive Results Associated When Using Remel M4RT Viral Transport Media
• March 3, 2021VITROS Chemistry Products VersaTips… Class IIA deformity affecting a specific lot of VITROS¿ Chemistry Products VersaTips. Deformed VersaTips results may be biased by up to +/-16% for both…
• Jan. 20, 2021VITROS Chemistry Products TP Slides- IVD measure total protein (TP)… and 1 more product Class IIEltrombopag Interference for VITROS Chemistry Products TP Slides and VITROS XT Chemistry Products ALB-TP Slides
• Jan. 13, 2021enGen Laboratory Automation System… and 1 more product Class IIA software anomaly may cause an aliquoted sample to be labelled as the incorrect sample. This may lead to results being associated with the wrong…
• Jan. 13, 2021VITROS Chemistry Products CKMB Slides: (1)VITROS CKMB Slides (60 Slide cartridge) Product Code:8058232… Class IIVITROS Chemistry Products CKMB Slides Potential for Falsely Elevated Results Due to CK-MM Interference
• Nov. 25, 2020VITROS Chemistry Products Performance Verifier II-For in vitro diagnostic use only.VITROS Chemistry Products… Class IIIProduct instability; biased ALKP values obtained from VITROS Chemistry Products Performance Verifier II Lot Q7692 when stored unopened at…
• Nov. 25, 2020VITROS Immunodiagnostic Products-SARS-CoV-2 IgG Calibrator… and 1 more product Class IIElevated sample results signal/cutoff (s/c) values when using eight (8) lots of VITROS immunodiagnostic Products Anti-SARS-CoV-2 IgG Calibrator and…
• Sept. 2, 2020VITROS XT3400 Chemistry System… and 1 more product Class IIWhen processing MicroSlides, slides that utilize Slot 18 in the CM rotor may be mis-positioned. As a result, certain VITROS MicroSlides may produce…
• Sept. 2, 2020VITROS Chemistry Products TBIL Slides- 5 PACK/300 SLDS In vitro… and 2 more products Class IIEtrombopag Interference for VITROS Chemistry Products: TBIL Slides, VITROS BuBc Slides and VITROS XT TBIL-ALKP Slides
• Aug. 19, 2020VITROS Anti-SARS-CoV-2 Total Reagent… and 1 more product Class IIThe reagent bottles may be swapped within the reagent pack, which may lead to false negative results or delayed results due to calibration failures…
• July 8, 2020VITROS 3600 Immunodiagnostic System Software Versions 3.3.3 and below… and 4 more products Class IIModifications to MicroWell Qualitative Assay Parameters Not Retained- may be inadvertently reset to default in certain circumstances
• June 24, 2020VITROS Chemistry Product AMYL Slides Reagent… and 3 more products Class IIMultiple coatings of VITROS Chemistry Products AMYL Slides are showing imprecision on control fluids when compared to the expected within lab SD as…
• May 20, 2020VITROS Chemistry Products CKMB Slides… and 1 more product Class IIThe Spanish and Swedish language versions of the IFU state that the assay can be tested with Plasma which is false and could result in biased results.
• May 6, 2020VITROS Immunodiagnostic Products TT4 Reagent Pack… Class IIIThe specified reagent packs exhibit an increase in the frequency of unsuccessful calibrations.
• Feb. 19, 2020VITROS Chemistry Products Calibrator Kit 2- IVD calibrator for VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry… Class IIPotential for Negatively Biased Na+ Urine Results Using Several Lots of VITROS Chemistry Products Calibrator Kit 2
• Jan. 1, 20207% BSA (Bovine Serum Albumin)… and 1 more product Class IIPotential for the instability of the diluents VITROS 7% BSA (Product Code 8262487) and VITROS Urine Electrolyte Diluent (UED) (Product Code 1110352)…
• Nov. 13, 2019VITROS chemistry Products Cl- Slides… and 2 more products Class IIUsers may experience intermittent slide dispense issues with some cartridges due to the anti-backup platen failing to advance inside the cartridge.
• Aug. 14, 2019VITROS Chemistry Products GLU Slides-Product Code:1707801… Class IIPotentially Biased Results using VITROS Chemistry Products GLU Slides
• Aug. 14, 2019VITROS 250 Chemistry System… and 11 more products Class IIPotential Unsuccessful Calibration Due to Software Anomaly in VITROS System
• July 10, 2019VITROS 250 Chemistry System… and 3 more products Class IIPotential negative drift in Creatine Kinase (CK) results when used on the VITROS 250 and 350 Systems.
• May 29, 2019VITROS XT 7600 Integrated System… Class IIPotential for sample fluid to be dispensed to an incorrect position on the MicroSlide, potentially leading to erroneous assay results being reported
• May 15, 2019VITROS¿ 5600 Integrated System -Software V3.3.2 & below Product Code… and 6 more products Class IILuminometer Malfunction May Cause Inability to Process MicroWell Assays on VITROS¿ Systems
• May 1, 2019VITROS XT 7600 Integrated System… Class IIOne of the software algorithms used to detect sample dispense errors was inadvertently disabled. Because of this, sample dispense errors may lead to…
• March 20, 2019VITROS Chemistry Products Na+ Slides… Class IIImprecision in the affected lot may produce negatively or positively biased patient sample and quality control fluid results.
• Feb. 27, 2019VITROS Chemistry Products VALP Reagent Pack… Class IINegative bias results when using VITROS VALP Reagent, GEN 25.
• Feb. 27, 2019Vitros Myoglobin Calibrators… Class IIA stability issue in the calibrators may cause calibration failures or atypical Quality Control results following a successful calibration.
• Jan. 9, 2019VITROS Anti-HBe Reagent Pack… and 2 more products Class IIThe firm is extending their previous July 2018 recall to include additional product codes. Biased results may occur for these additional products at…
• Dec. 26, 2018VITROS 5600 Integrated System… and 3 more products Class IISoftware anomaly may incorrectly extend the on-analyzer stability time for a loaded VITROS Reagent.
• Nov. 28, 2018VITROS¿ Chemistry Products dLDL Reagent-GENs 26 & 27… Class IIVITROS Chemistry Products dLDL Reagent GENs 26 and 27, negatively biased results
• Nov. 14, 2018VITROS Immunodiagnostic Products Vitamin B12 Reagent Pack 1/2… Class IIThe reagent pack exhibits the potential for an increased frequency of calibration failures.
• Oct. 17, 2018VITROS 5600 Integrated System-For use in the in vitro quantitative… and 1 more product Class IIPotential for the VITROS 5600 Integrated System to dispense an insufficient sample volume onto a MicroSlide without suppressing the potentially…
• Oct. 10, 2018VITROS Sodium Slides… Class IIPotential for positively biased results
• Oct. 10, 2018VITROS Immunodiagnostic Products… and 3 more products Class IIThe recalling firm determined that biased results may occur for specific VITROS Immunodiagnostic Products (MicroWell Assays) at biotin concentrations…
• Sept. 26, 2018VITROS Chemistry Products CREA Slides… Class IIIThe slides did not meet the current claims for Limit of Blank (LoB), Limit of Detection (LoD) and Limit of Quantification (LoQ) for serum and urine…
• Sept. 26, 2018VITROS Chemistry Products Cl- Slides… Class IIIThe slides failed to meet current claims for Limit of Blank (LoB), Limit of Detection (LoD) and Limit of Quantification (LoQ) for urine samples. The…
• Sept. 19, 2018VITROS Chemistry Products Cl- Slides… and 1 more product Class IIIThe slides do not meet the maximum allowable interference (MAI) claims for triglyceride interference when using serum samples. Triglyceride…
• July 11, 2018VITROS Chemistry Products PHYT Slides… Class IIThere is a potential for imprecise results when using the slides. Increase in imprecision when using PHYT coating 0165. This leads to higher and…
• March 14, 2018VITROS Chemistry Products DAT Performance Verifier I in vitro… and 4 more products Class IIThis product is not meeting the current storage labeling for unopened VITROS DAT Performance Verifiers causing customers to obtain lower than…
• March 7, 2018VITROS Chemistry Products Performance Verifier is used as an assayed control to monitor the performance on… Class IIIVITROS Performance Verifier II (PVII) Lot K4852 does not meet long term stability requirements for the AST Analyte (only) when the product is stored…
• Jan. 3, 2018VITROS Chemistry Products PHYT Slides… Class IIThe firm identified the potential for biased results to be generated when processing VITROS PHYT Slide product with citrate plasma specimen samples.…
• Dec. 20, 2017enGen Track System with TCAutomation Software Version 4.2 Class IIA software anomaly with TCA Software V4.2 may potentially cause a delay in reporting of results due to patient samples being routed to an unintended…
• May 24, 2017enGen (TM) Laboratory Automation Systems using all TCAutomation(TM) Software Versions with the InOut… Class IISoftware anomaly; Thermo-Fisher Scientific initially discovered and Ortho-Clinical Diagnostics, subsequently, confirmed a software anomaly that may…
• May 3, 2017VITROS Chemistry Products VANC Reagent… Class IIPotential for biased results generated using the specific lots of VITROS VANC Reagent. This can occur after the reagent packs are loaded onto the…
• April 19, 2017VITROS Immunodiagnostic Products NT-pro BNP Reagent Pack… Class IIIncreased frequency of calibration failures for VITROS Immunodiagnostic Products NT-proBNP Reagent Lots 1568, 1570, 1580 and 1590, due to background…
• March 22, 2017VITROS Chemistry Products Li (Lithium) Slides… Class IIIntermittent imprecision in results generated using two specific lots of VITROS Li Slides.
• Feb. 15, 2017VITROS Chemistry Products FS Calibrator 1… Class IIIThe company received a customer complaint for the inability to calibrate VITROS Chemistry Products dLDL Reagent when using VITROS FS Calibrator 1…
• Feb. 15, 2017VITROS Chemistry Products UPRO Slides… Class IIThere is a potential for variable negatively and positively biased urine protein results using VITROS UPRO Slides.
• Feb. 8, 2017VITROS Na+ Slides… Class IIThere is a potential for biased results to be generated over the 10 day on-analyzer storage limit when using VITROS Na+ Slide cartridges warmed at…
• Jan. 4, 2017VITROS Immunodiagnostic Products Intact PTH Reagent Pack: 1) UPN 10758750006287 / Product Code 6802892… Class IIThe device defect is a positive bias of up to 20% relative to the currently marketed Roche device. In addition, the firm states that during the…
• Dec. 28, 2016VITROS CRP Slides: 1) VITROS¿ Chemistry Products CRP Slides (250 slides per sales unit)… Class IIICRP samples diluted using VITROS Chemistry Products Specialty Diluent, VITROS Chemistry Products FS Diluent Pack 3, or a sample with a low…
• Nov. 2, 2016VITROS Immunodiagnostic Products HBsAg Controls… Class IIIThe signal/cutoff (s/c) results may increase throughout the open-reconstituted timeframe of the allowed 5 days. Increased results may occur on both…
• Nov. 2, 2016enGen Laboratory Automation System (Product Code ENGEN) configured with Thermo Scientific Centrifuge Module… Class IIOrtho confirmed that it is possible for the mis-association of sample identification and assay results due to an error with Thermo Fishers…
• Oct. 26, 2016VITROS Chemistry Products GLU Slides… and 3 more products Class IIOrtho Clinical Diagnostics confirmed that N-Acetylcysteine (NAC), a drug used for acetaminophen overdose, mucolytic therapy and is used as…
• Sept. 21, 2016The VITROS¿ Chemistry Products Calibrator Kit 31… Class IIIThere is an incorrect value (data/calibration mathematics) on ADDs. This incorrect value will prevent a successful calibration of the assay.
• Aug. 24, 2016VITROS Immunodiagnostic Products TSH Reagent Pack… Class IIIA field correction was issued by the firm for VITROS TSH reagent lot 5040 due to a higher than expected frequency of customer calibration curves…
• Aug. 17, 2016VITROS Immunodiagnostic Products Estradiol Reagent Pack… Class IIOrtho Clinical Diagnostics has issued a recall of their VITROS immunodiagnostics Estradiol Reagent assay. The firm was made aware of a potential…
• Aug. 10, 2016VITROS Immunodiagnostic Products Total T4 Reagent Pack… Class IIOrtho-Clinical Diagnostics confirmed that sample results generated from VITROS Immunodiagnostic Products Total T4 Reagent Packs may show a negative…
• Aug. 3, 2016VITROS Chemistry Products Ca Slides… Class IIOrtho Clinical Diagnostics (OCD) confirmed a potential for biased calcium (Ca) results to be generated when using VITROS Ca Slides, GEN29, and the…
• July 20, 2016VITROS Immunodiagnostic Products AFP Reagent Pack… Class IIIOrtho Clinical Diagnostics (OCD) confirmed that specific lots of VITROS Immunodiagnostic Products AFP Reagent Pack product exhibit an increase in the…
• July 20, 2016enGen Laboratory Automation System… Class IIIIf the user selects the Comment or Interpretation option (in the enGEN .gsb file), and the numerical results fall between Negative and Reactive, the…
• July 13, 2016VITROS Chemistry Products Calibrator Kit 29… Class IIIOrtho Clinical Diagnostics started receiving customer complaints for biased results when using VITROS dTIBC Reagent GEN 30 product. Ortho's…
• June 15, 2016VITROS 3600 Immunodiagnostic System… and 1 more product Class IIOrtho Clinical Diagnostics confirmed a software timing anomaly in which the VITROS 3600 and 5600 Systems may unexpectedly aspirate from or dispense…
• June 1, 20161) VITROS¿ Immunodiagnostic Products Total Beta-hCG II Reagent Pack (Unique Device Identifier No… Class IIWhen testing was conducted using certain lots, VITROS¿ Systems generated results within the measuring range for samples known to not contain…
• May 4, 2016enGen (TM) Laboratory Automation System configured with Thermo Scientific Recapper Module (230V or 110V --… Class IIThe electrical cable that supplies power to the cap vibratory feeder of the Recapper Module may loosen from its correct position above the vibration…
• April 13, 2016VITROS 5600 Integrated System… Class IIThe two sets of wires (4 total wires) exiting from the EMI filters were switched, creating a situation where a module that is intended to be…
• March 16, 2016VITROS 250 Chemistry Systems… and 4 more products Class IIIncreased U90-382 or 6LU condition codes generated by VITROS 250, 350, 5,1 FS, 4600 and 5600 Chemistry Systems when using Calibrator Kit 9, Lot 954.…
• Jan. 20, 2016VITROS 3600 Chemistry System… and 3 more products Class IISoftware anomaly may allow VITROS Systems to sample and process assays while the fluids and reagent temperatures are not in the required temperature…
• Nov. 11, 2015VITROS 5,1 FS Chemistry System… Class IISoftware Anomaly during ADD Installation on VITROS 5,1 FS Chemistry Systems using Software Versions 2.2.1 through 2.8. The user modified parameters…
• Nov. 11, 2015VITROS Chemistry Products Calibrator Kit 9 Calibrator… Class IIIThe firm is conducting a product correction due to an increase in U90-382 or 6LU condition codes (wash errors) when using VITROS Calibrator Kit 9…
• Sept. 9, 2015VITROS 5,1 FS Chemistry System… Class IISoftware anomaly may occur during the installation of an Assay Data Diskette (ADD) using Software Versions 2.2.1 through 2.8. If the user is…
• June 17, 2015VITROS 4600 Chemistry System… and 1 more product Class IISoftware anomaly allows testing of multiple assays using a single urine specimen, regardless of the pretreatment requirements for each selected…
• June 17, 2015VITROS 5,1 FS Chemistry System… and 1 more product Class IISoftware anomaly regarding urine samples that require acidified pretreatment. The software has allowed urine samples for assays that require…
• June 17, 2015enGen Laboratory Automation System (enGen System)… Class IIRecapper Caps may fall off of, or be knocked from sample tubes placed in the storage racks of entry/exit modules. The gripper may grab a tube at the…
• June 10, 2015VITROS Immunodiagnostic Products Signal Reagent… Class IIIThe Immunodiagnostic Products Signal Reagent, Lot 3082 as the reagent packs may contain blank labels.
• May 6, 2015Software Version 2.8 & Below on VITROS 5,1 FS Chemistry Systems… Class IISoftware Anomaly; It is possible for the device to process samples with a cartridge other than the intended cartridge, potentially leading to…
• March 18, 2015VITROS Hand-held Barcode Scanner… Class IIIn combination with the Batch Programming option (only) for programming samples, the hand-held barcode scanner unexpectedly skips sample cup…
• Jan. 28, 2015VITROS Software Version 3.1 utilized on the following systems: 1) 4600 Chemistry Systems (VITROS 5,1 FS… Class IIICalibration may not occur when using calibrator barcode labels supplied with VITROS Chemisty Products Calibrator Kit 2.
• Jan. 21, 2015VITROS 3600 Immunodiagnostic System… and 2 more products Class IISoftware Anomaly: the firm has identified an anomaly with VITROS System Software Version 3.1 and below, and determined that the software may not…
• Dec. 31, 2014VITROS CHEMISTRY PRODUCTS TRIG Slides… Class IIPotential for biased results using the specific lot of VITROS CHEMISTRY PRODUCTS TRIG slides.
• Oct. 22, 2014VITROS 4600 Chemistry System (VITROS 5,1 FS System family member)… and 1 more product Class IIOrtho Clinical Diagnostics (OCD) identified an anomaly with Software Version 3.0 and below on the VITROS 4600 Chemistry Systems and VITROS Integrated…
• Oct. 8, 2014VITROS Chemistry Products PHYT (Phenytoin) Slides… Class IIOrtho Clinical Diagnostics identified a potential for biased results to be generated when using VITROS PHYT Slides, Lot 2613-0150-4913. Some…
• Oct. 1, 2014VITROS Immunodiagnostic Products Anti-HCV Reagent Pack for in vitro qualitative detection of immunoglobulin G… Class IIVITROS Immunodiagnostic Products Anti-HCV kit lot 9090 has been observed producing sporadic lower than expected VITROS Anti-HCV test results due to…
• Aug. 20, 2014VITROS¿ Chemistry Products CDM PROM Calibration Data Module Rev… Class IIInability to calibrate or use VITROS NH3 DT Slides, GEN 59 with VITROS Chemistry Products DT Calibrator Kit, Lot 44 when CDM PROM 0168 or 0169 is…
• Aug. 20, 2014VITROS¿ Immunodiagnostic Products CA 19-9 Calibrators and Reagent Packs… Class IICustomers may receive positively biased results when using VITROS¿ Immunodiagnostic Products CA 19-9 Total Reagent Packs, Lot 1320 and VITROS¿ CA…
• Aug. 13, 2014VITROS 3600 Immunodiagnostic System --- For use in the in vitro… and 2 more products Class IIOrtho Clinical Diagnostics has identified an anomaly with VITROS System Software Version 3.0 and below. Internal testing confirmed that under very…
• June 25, 2014VITROS (R) Chemistry Products Calibrator Kit 17… and 1 more product Class IICalibrator values assigned for the calibrator kit lots were released using a reference method that was undergoing validation for a new lot of…
• June 18, 2014enGen (TM) Laboratory Automation System Configured with TCAutomation" Software v3.5 -- For in vitro… Class IISoftware anomaly: potential buffer timeout issues when using enGen (TM) Laboratory Automation Systems Configured with TCAutomation (TM) Software v3.5.
• June 18, 2014enGen Laboratory Automation Systems (enGen) with TCAutomation -- For in vitro quantitative measurement of a… Class IISoftware anomaly: potential for delay in the reporting of patient sample test results when using enGen with TCAutomation Software v2.6 , v3.2 and…
• June 18, 2014VITROS 4600 Chemistry System… and 2 more products Class IIPotential for biased results when a Multiple Window (MW) code is associated with results generated by the VITROS 4600 Chemistry System, the VITROS…
• June 11, 2014enGen (TM) Laboratory Automation System configured with Data Innovations… Class IISoftware Anomaly: Ortho Clinical Diagnostics (OCD) has become aware that if a sample requires follow-up action, such as dilution or retesting due to…
• May 28, 2014VITROS TT4 Calibrator For the quantitative measurement of total thyroxine (T4) in human serum and plasma… Class IITotal T4 Calibrators and Reagent Packs may have calibration failures or low Quality Control results.
• May 7, 2014VITROS Chemistry Products Specialty Diluent… and 1 more product Class IIOrtho Clinical Diagnostics (OCD) confirmed the potential for lower than expected C-Reactive Protein (CRP) results only to be generated when using…
• April 30, 2014VITROS Chemistry Products CDM PROM (Calibration Data Module) No… Class IICustomers were unable to calibrate, or use previously calibrated, VITROS DT CRSC slides (REF/Product Code 6802721), GEN 82, on the VITROS DT II…
• April 23, 2014VITROS Chemistry Products CRBM Slides… Class IIThe firm identified a potential for biased carbamazepine (CRBM) results to be generated when using VITROS CRBM Slides, Lot 3920-0080-8403.
• March 26, 2014VITROS Chemistry Products White Reference Slides… Class IIAn incorrect assay value (0.3785) was printed on the product carton for the 460 nm wavelength (filter) that may cause a delay in the ability to…
• March 19, 2014VITROS Immunodiagnostic Products 25-OH Vitamin D Total Calibrators… Class IIIOrtho Clinical Diagnostics has determined that the VITROS Immunodiagnostic Products 25-OH Vitamin D Total Calibrators, Lots 0091 through 0235, used…
• March 5, 2014VITROS Chemistry Products Na+ Slides… and 1 more product Class IIOrtho Clinical Diagnostics has recalled VITROS Chemistry Products Na+ Slides and the Calibrator Kit 2 due to false positive serum and plasma sample…
• Feb. 19, 2014VITROS Chemistry Products Mixing Cup Arrays utilized on VITROS 250 & 350 Chemistry Systems Product Usage… Class IIOrtho Clinical Diagnostics issued a product correction notification for VITROS Chemistry Mixing Cup Arrays utilized on VITROS 250 and VITROS 350…
• Feb. 19, 2014enGen Track System with enGen Select v5.0 with autoverification… and 1 more product Class IIOrtho Clinical Diagnostics issued an Urgent Product Correction Notification involving the enGen Select V5.0 & enGen Custom v3.2.2 due to an anomaly…
• Jan. 29, 2014VITROS Chemistry Products COCM Reagent Class IIInaccurate quality control results.
• Jan. 1, 2014VITROS Anti-HBs Calibrators & VITROS Anti-HBs Reagent Packs Class IIOrtho Clinical Diagnostics issued a Product Correction Notification for VITROS Immunodiagnostic Products Anti-HBs Calibrators and Anti-HBs…
• Dec. 25, 2013VITROS CA 125 II Calibrators For use in the calibration of the VITROS ECi/ECiQ Immunodiagnostic Systems… Class IIOrtho Clinical Diagnostics issued a Product Correction Notification for VITROS Immunodiagnostic Products CA 125 II Reagent Pack and Calibrators due…
• Nov. 27, 2013VITROS Chemistry Products ACET Slides… and 36 more products Class IIOrtho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues.
• Aug. 21, 2013Colorimetric (CM)/ Rate (RT) incubator wear pads… Class IIOrtho Clinical Diagnostics is recalling CM/RT wear pads which are a component in the CM/RT incubator due to becoming worn before their replacement.
• July 10, 20131) VITROS 5,1 FS Chemistry System (product code 6801375) and 2)… and 4 more products Class IIThere is evidence that an electrical short within the systems connector has caused an accumulation of heat which has radiated back through the wiring…
• July 3, 2013VITROS Chemistry Products K+ (Potassium) Slides (Reagent)… and 1 more product Class IIIWhile performing interval testing, Ortho Clinical Diagnostics (OCD) determined that a surfactant was unintentionally added to VITROS Chemistry…
• June 26, 2013VITROS Chemistry Products-HCY Reagent packaged in a kit carton… Class IIThe firm is recalling the specific lot due to lower than expected results.
• May 29, 2013VITROS Immunodiagnostic Products CK-MB Calibrators… Class IIIInternal testing demonstrated that opened-reconstituted VITROS CK-MB Calibrators stored at -20 degrees Celsius (-4 degrees Farenheit) generated…
• May 1, 2013VITROS¿ Immunodiagnostic Products Anti-HBs (total antibody to hepatitis B surface antigen (anti-HBs)) Reagent… Class IIIOrtho Clinical Diagnostics is recalling certain lots of the Vitros Anti-HBs Reagent packs an inability to obtain a valid calibration.
• May 1, 2013VITROS Chemistry Products PHBR (Phenobarbital) Slides… Class IIOrtho Clinical Diagnostics (OCD) received customer complaints of intermittent imprecision, outliers, or shifts in accuracy and control fluid values…
• April 24, 2013VITROS 5,1 FS Chemistry System… and 2 more products Class IIOrtho-Clinical Diagnostics, Inc. (OCD) determined that extension springs on some VITROS¿ Systems may be out of its manufacturing specifications.…
• Feb. 6, 2013Ortho Clinical Diagnostics VITROS¿ Chemistry Products Vapor Adsorption Cartridge REF/CAT No… Class IISome VITROS¿ Chemistry Products Vapor Adsorption Cartridge CAT No. 6800100 cartons incorrectly contain a Particulate Cartridge Part No. J19612. In…
• Aug. 22, 2012VITROS Chemistry Products DGXN Slides --- [REF] 834 3386… Class IIOrtho Clinical Diagnostics revised the VITROS Chemistry Products DGXN Slides Instructions for Use (IFU) and removed heparin plasma as a recommended…
• Aug. 1, 2012VITROS 5,1 FS System Software For use in the in-vitro quantitative… and 2 more products Class IIsoftware automatically switches the lot when a vancomycin (VANC) or valproic acid (VALP) reagent is depleted or the operator manually changes the lot…
• June 1, 2012VITROS 5600 Integrated System Software Version 1.6 & Below Product Usage: For use in the in vitro… Ortho Clinical Diagnostics is recalling VITROS 5600 Integrated System Software Version 1.6 and below because of an anomaly that may inadvertently add…
• April 26, 2012VITROS® 3600 Immunodiagnostic System Product Usage: For use in the in… and 4 more products Ortho-Clinical Diagnostics is recalling VITROS Chemistry Systems due to possible internal hard drive failure.
• March 26, 2012VITROS Chemistry Products --- dHDL Slides --- Ortho Clinical Diagnostics… Ortho Clinical Diagnostics (OCD) has revised the VITROS dHDL Slides Instructions for Use (IFU) and removed EDTA plasma as a recommended sample type.
• March 22, 2012VITROS Chemistry Products --- ALT Slides --- [REF] 165 5281 --- [Mfg Symbol] Ortho-Clinical Diagnostics… Ortho Clinical Diagnostics received complaints of lower than expected results (< 6 U/L) for samples that were known to be outside of the measuring…
• Feb. 28, 2012VITROS Chemistry Products PHBR Slides… Ortho Clinical Diagnostics (OCD) received customer complaints of intermittent imprecision, outliers, or shifts in control fluid values when using…
• Feb. 21, 2012VITROS 3600 Immunodiagnostics Systems… and 1 more product Ortho Clinical Diagnostics (OCD) received customer complaints regarding the loss of calibration data following the installation of a development…
• Feb. 8, 2012VITROS Valproic Acid (VALP) Reagent… Results using VITROS Chemistry Products VALP Reagent were negatively biased compared to other manufacturers. OCD confirmed that patient results were…
• Feb. 7, 2012VITROS Chemistry Products Calibrator Kit 24… Ortho Clinical Diagnostics received numerous complaints of lower than expected results for control fluids and patient samples upon initial…
• Jan. 27, 2012VITROS ECi Immunodiagnostic System… and 1 more product Software defect; Ortho Clinical Diagnostics received complaints of observed results from diluted samples that were reported as <2.39 mIU/mL (IU/L)…
• Jan. 27, 2012VITROS Chemistry Products DT Calibrator Kit… Ortho Clinical Diagnostics (OCD) was notified by customers of negatively biased quality control results obtained while using VITROS Chemistry…
• Jan. 26, 2012enGen(TM) Laboratory Automation Systems configured with Hettich Rotanta 46 RSC Robotic Centrifuges… Ortho Clinical Diagnostics received complaints of centrifuge buckets disconnecting from their supports during centrifugation when using the Hettich…
• Jan. 11, 2012VITROS Chemistry Products Calibrator Kit 16… Ortho Clinical Diagnostics is recalling Lot 1630 of VITROS Calibrator Kit 16 because it will not likely meet its specified 12 months of stability.
• March 28, 2011The enGenTM Laboratory Automation System consists of 3 main components including Instrument Management… A software anomaly that can occur with analyzers connected to the Bypass modules listed below on an enGen" Laboratory Automation System using…
• Aug. 16, 2007VITROS 5,1 FS (Fusion Series) Chemistry System Software Version 2.2.1… Software design. The firm received a customer complaint regarding a qualitative positive THC (Cannabinoids) result obtained from a THC quality…
• May 26, 2007VITROS Immunodiagnostic Products Troponin I Reagent Pack… Quality control and patient results can be lower than expected when the true Troponin I value is less than or equal to 0.2 ng/mL which may result in…
• April 14, 2007VITROS Immunodiagnostics Products HBsAg Reagent Pack… Complaints of an increase in ''Reactive'' results with patient samples collected in sodium citrate or EDTA plasma collection tubes when using these…
• Dec. 5, 2006VITROS Chemistry Products LIPA Slides GEN 48… The firm identified circumstances in which biased results or calibration failures can be observed when using any lot of VITROS LIPA slides if they…
• Nov. 4, 2006VITROS Chemistry Products GLU DT Slides GEN 56… Positively biased results when using the VITROS Chemistry Products GLU DT Slides GEN 56.
• Oct. 27, 2006VITROS WorkCentre… Incorrect result calculations can occur (only affects derived results calculated by the VITROS WorkCentre)
• April 20, 2006VITROS Immunodiagnostic Products Signal Reagent… Firm received complaints of biased results when using VITROS Signal Reagent, Lots 8350 and 8530. VITROS Signal Reagent is used with the VITROS…
• Jan. 6, 2006Vitros Immunodiagnostic HBsAg CONFIRMATORY KIT * REF 680 1324… Increased background signal of the sample diluent in the affected Confirmatory Kits could cause some results to be classified as 'Not Confirmed'.
• Nov. 18, 2005VITROS VANC (vancoymycin) Reagent… Negatively biased results can be observed when the reagent pack has less than five tests remaining and has been on the analyzer greater than 2 days.
• Nov. 15, 2005Vitros ECi Immunodiagnostic System… When using Vitro ECi Immunodiagnostic System with Vitros Anti-HBc IgM Reagent Packs and Anti-HAV IgM Reagent Packs, results of the 1st of two…
• Sept. 1, 2005VITROS Chemistry GENT Reagent REF 680 1711… Negatively biased results can be observed when the reagent pack has less than 12 tests remaining and has been on the analyzer greater than 24 hours.
• July 16, 2005Vitros Chemistry CRBM Slides… Falsely elevated Carbamazepine results.
• June 21, 2005VITROS Immunodiagnostic Products TOTAL T4 REAGENT PACK… Potential for positively biased results in QC and patient samples.
• June 4, 2005VITROS VALP Reagent… Negatively biased results may be observed when the reagent is stored on the VITROS 5,1FS Chemistry System for less than seven days.
• Jan. 8, 2005Vitros CRP (C-Reactive Protein) Slides… Results may be negatively biased due to a non-linear response at the upper end of the Reportable (Dynamic) Range.
• Sept. 18, 2004VITROS CRP Slides: (1) Cat # 192 6740… The Immuno-rate (IR) wash detection algorithm may result in inappropriate wash detections.
• July 20, 2004Vitros Immunodiagnostic Products TROPONIN I Reagent Packs… Random occurrence of false positive test results.
• Jan. 6, 2004Vitros Immunodiagnostic Products CEA REAGENT PACK… Reagent packs may contain wells that produce a low light signal that could result in calibration failures or negatively biased results.
• Jan. 6, 2004Vitros Immunodiagnostic Products CK-MB REAGENT PACK… Reagent packs may contain wells that produce a low light signal that could result in calibration failures or negatively biased results.
• Sept. 11, 2003Vitros Chemistry *** GLU (glucose) Slides *** 5 cartridges each… and 1 more product Results of glucose measurements on sodium fluoride/potassium oxalate specimens can be negatively biased when using Vitros GLU and GLU DT slides…
• June 5, 2003Vitros TP Slides… Slides may exhibit random, elevated imprecision of results.
• Feb. 21, 2003Vitros Immunodiagnostic Products *** UNIVERSAL WASH REAGENT *** for in vitro diagnostic use only… Label printing irregularities on cartons and/or bottles.
• Feb. 21, 2003CARTON LABEL: ''TDM Performance Verifier I''… Cartons labeled 'TDM Performance Verifier I' may contain TDM Performance Verified II.

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