https://plainrecords.com/brand/ortho-clinical-diagnostics/New recalls of Ortho-Clinical Diagnostics from FDA, CPSC and NHTSA records.en-ushttps://plainrecords.com/recall/device/z-2559-2025/https://plainrecords.com/recall/device/z-2559-2025/Wed, 24 Sep 2025 00:00:00 +0000VITROS Chemistry Products LAC Slides on VITROS XT 3400 and VITROS XT 7600 Systems are experiencing an increased occurrence of calibration failure related to lots from coating 0130 and above with Condition Code TH4-63J during calibration, causing the delay of lac test results and potentially impact patient management. The issue was identified by QuidelOrtho through an increase in customer…https://plainrecords.com/recall/device/z-2335-2025/https://plainrecords.com/recall/device/z-2335-2025/Wed, 27 Aug 2025 00:00:00 +0000Generations 67 and above of VITROS Ca Slides are experiencing an increased occurrence of Condition Code TH4-63J during calibration on VITROS XT 3400 and VITROS XT 7600 Systems, causing calibration failures that delay calcium test results and potentially impact patient management. The imaging reflectometer algorithm detects excessive "spikes" (imperfections) in slide images and generates the…https://plainrecords.com/recall/device/z-2120-2025/https://plainrecords.com/recall/device/z-2120-2025/Wed, 23 Jul 2025 00:00:00 +0000Quality control (QC) drift when certain lots of Performance Verifiers (PVs) are used with certain lots of cholinesterase enzyme (CHE) slides. This drift occurs when the PVs are used 2-7 days after reconstitution; however, the label stability claims for the PV fluids is 7 days following reconstitution. This may lead to inaccurate QC results. The use of the PVs when the QC results are outside of…https://plainrecords.com/recall/device/z-2073-2025/https://plainrecords.com/recall/device/z-2073-2025/Wed, 09 Jul 2025 00:00:00 +0000Lots from Generation (GEN) 15 of VITROS Chemistry Products OP Reagent may generate lower than expected quality control (QC) results. If the customer is unable to get passing quality control results, then the customer would be unable to run the OP-LO protocol leading to a potential delay in patient results.https://plainrecords.com/recall/device/z-2038-2025/https://plainrecords.com/recall/device/z-2038-2025/Wed, 09 Jul 2025 00:00:00 +0000A 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 Use Expired Reagents setting is not enabled if a shelf expiration date is omitted during manual loading. The issue was identified by a customer complaint, in which a CREA Urine test was processed with an RE (Reagent Expired) code, even though the…https://plainrecords.com/recall/device/z-1948-2025/https://plainrecords.com/recall/device/z-1948-2025/Wed, 18 Jun 2025 00:00:00 +0000It 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) results (only) of the assay.https://plainrecords.com/recall/device/z-1876-2025/https://plainrecords.com/recall/device/z-1876-2025/Wed, 04 Jun 2025 00:00:00 +0000Product was incorrectly assigned GEN 88 instead of GEN 83 on product carton, foil wrapper, and cartridge (cart) label.https://plainrecords.com/recall/device/z-1005-2025/https://plainrecords.com/recall/device/z-1005-2025/Wed, 29 Jan 2025 00:00:00 +0000The 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 shelf-life expiration date. This could result in the use of expired products, which would increase the risk of no results or erroneous results from the instrument.https://plainrecords.com/recall/device/z-0535-2025/https://plainrecords.com/recall/device/z-0535-2025/Wed, 04 Dec 2024 00:00:00 +0000May 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 mg/L range) while the samples having higher than 90 mg/L. User no way to know if the sample has to be diluted to measure again.https://plainrecords.com/recall/device/z-2684-2024/https://plainrecords.com/recall/device/z-2684-2024/Wed, 28 Aug 2024 00:00:00 +0000The 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 through the MicroSlide Subsystem of the VITROS XT 3400 or VITROS XT 7600 analyzer. This dust and debris may then settle onto VITROS Na+ (Sodium) Slides as they are processed through the same MicroSlide Subsystem, potentially resulting in an increase…https://plainrecords.com/recall/device/z-2580-2024/https://plainrecords.com/recall/device/z-2580-2024/Wed, 21 Aug 2024 00:00:00 +0000It was confirmed that fibrinogen in patient plasma samples precipitates out of solution upon the addition of folate stabilizer reagent as part of the pre-treatment process causing the increase in "TM5-4MB" condition codes which lead to a delay of results.https://plainrecords.com/recall/device/z-2266-2024/https://plainrecords.com/recall/device/z-2266-2024/Wed, 10 Jul 2024 00:00:00 +0000VITROS Chemistry Products FS Diluent Pack 3, Lot 01-1645 may cause results to be negatively biased when used to dilute patient samples tested with VITROS Chemistry Products CRP Slides.https://plainrecords.com/recall/device/z-2245-2024/https://plainrecords.com/recall/device/z-2245-2024/Wed, 10 Jul 2024 00:00:00 +0000Kit 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 true expiration and the customer does not have their Assay Data Disk (ADD) updated, the system will allow them to use the expired calibrator which may bias the results. However, at this time the calibrator is within its use date and will function…https://plainrecords.com/recall/device/z-2142-2024/https://plainrecords.com/recall/device/z-2142-2024/Wed, 19 Jun 2024 00:00:00 +0000Potential for positively biased results due to signal reduction over shelf life.https://plainrecords.com/recall/device/z-2019-2024/https://plainrecords.com/recall/device/z-2019-2024/Wed, 12 Jun 2024 00:00:00 +0000The results generated by the VITROS Immunodiagnostic Products Vitamin B12 Range Verifier Lot# 1200 RV Level 2 may cause range verification failure. The issue is detectable by the user when the product fails to meet the required range during processing of RV Level 2 of this lot. There is a potential for a delay in patient test results should the user have a need to switch to an alternate method of…https://plainrecords.com/recall/device/z-1372-2024/https://plainrecords.com/recall/device/z-1372-2024/Wed, 03 Apr 2024 00:00:00 +0000The issue was mismatched diluent lots assembled into VITRO Chemistry Products Performance Verifier I and II. This issue has the potential to cause erroneous Quality Control (QC) results that could lead to testing delays and erroneous patient results. This issue caused positive or negative bias in the quantification of sodium (Na+) and total carbon dioxide (ECO2). The incorrect diluent into the…https://plainrecords.com/recall/device/z-1229-2024/https://plainrecords.com/recall/device/z-1229-2024/Wed, 13 Mar 2024 00:00:00 +0000A 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 expected. When a new control is defined, configurable Westgard rules, if selected, are not flagged or reported with the applicable QC results if the statistical criteria is met. This may result in acceptance of QC results that do not meet acceptance…https://plainrecords.com/recall/device/z-1224-2024/https://plainrecords.com/recall/device/z-1224-2024/Wed, 13 Mar 2024 00:00:00 +0000A software defect affecting VITROS Systems running VITROS Software Versions 3.8.1 causes QC baseline statistics to not update as expected when changed by the user. This may cause erroneous patient results to be reported.https://plainrecords.com/recall/device/z-1220-2024/https://plainrecords.com/recall/device/z-1220-2024/Wed, 13 Mar 2024 00:00:00 +0000Potential For Aspiration from Unintended Sample Container During Sampling Center Processing on VITROS¿ 3600 Immunodiagnostic Systems and VITROS¿ 5600/XT 7600 Integrated Systems which may lead to erroneous test results.https://plainrecords.com/recall/device/z-0772-2024/https://plainrecords.com/recall/device/z-0772-2024/Wed, 31 Jan 2024 00:00:00 +0000Affected lots may experience increased calibration failures or an increase in falsely elevated results.https://plainrecords.com/recall/device/z-0712-2024/https://plainrecords.com/recall/device/z-0712-2024/Wed, 17 Jan 2024 00:00:00 +0000Ortho-Clinical Diagnostics, Inc. is recalling QMS Tacrolimus Calibrators, Lot 74859619 expiry date: May 11, 2024, due to improper storage that is expected to degrade the quality of the calibrator and render it unsuitable for use. Use of the affected lot may results in erroneous calibration results, causing delay in testing.https://plainrecords.com/recall/device/z-0543-2024/https://plainrecords.com/recall/device/z-0543-2024/Wed, 20 Dec 2023 00:00:00 +0000During planned monitoring of data post-release of Software Version 3.8.0 an increased occurrence of software issues relating to unresponsive subsystems, unresponsive user interface (sometimes referred to as a screen freeze), and/or printer disconnections was identified. The consequence of these issues would be a delay in reporting results due to the required system shutdowns to recover the…https://plainrecords.com/recall/device/z-0510-2024/https://plainrecords.com/recall/device/z-0510-2024/Wed, 13 Dec 2023 00:00:00 +0000Ortho Clinical Diagnostics (QuidelOrtho) confirmed during routine testing that some lots from Coating 3598 of VITROS ECO2 slides included carts which may contain consecutive slides that may not function as intended. These affected slides (potentially intermittent, consecutive slides within a cart or across consecutive carts) have an abnormality which may cause positively or negatively biased…https://plainrecords.com/recall/device/z-0236-2024/https://plainrecords.com/recall/device/z-0236-2024/Wed, 15 Nov 2023 00:00:00 +0000Products 1668409 and 8297749 may contain VITROS Lipase Slides with an abnormality which could cause -46% to +86% bias in lipase results depending on how the slides are used. Falsely low levels could result in a missed or delayed diagnosis of acute pancreatitis and may lead to diagnostic confusion in the setting of acute abdominal symptoms. Falsely elevated levels would not result in patient harm…https://plainrecords.com/recall/device/z-0008-2024/https://plainrecords.com/recall/device/z-0008-2024/Wed, 11 Oct 2023 00:00:00 +0000Ortho Clinical Diagnostics (QuidelOrtho) confirmed certain Proboscis/Piston Assemblies manufactured between 07-Apr-2022 (Date code: 040722) and 19-Dec-2022 (Date code: 121922) may not perform as intended due to an out-of-specification barrel component. This may cause VITROS VersaTips and/or VITROS MicroTips to be improperly seated on the proboscis, which may result in falsely elevated Gentamicin…https://plainrecords.com/recall/device/z-2623-2023/https://plainrecords.com/recall/device/z-2623-2023/Wed, 27 Sep 2023 00:00:00 +0000Samples containing high levels of ALKP (or an interfering substance) could deplete the available substrate in the reagent layer of a VITROS ALKP Slide and not post the substrate deleption (DP) code, which may result in the System reporting an incorrect value (lower than the actual value), which may result in missed or delayed diagnosis of liver disease.https://plainrecords.com/recall/device/z-2357-2023/https://plainrecords.com/recall/device/z-2357-2023/Wed, 16 Aug 2023 00:00:00 +0000Reagent packs could potentially contain incorrect wells, which will generate incorrect, and potentially false negative, results.https://plainrecords.com/recall/device/z-2225-2023/https://plainrecords.com/recall/device/z-2225-2023/Wed, 02 Aug 2023 00:00:00 +0000May not meet the stability specifications for shelf life outlined in the Instructions For Use (IFU).https://plainrecords.com/recall/device/z-2129-2023/https://plainrecords.com/recall/device/z-2129-2023/Wed, 19 Jul 2023 00:00:00 +0000Potential to cause biased results in the upper end of the reportable range for the quantitative measurement of Transferrin, C3, C4, IgA, IgG and IgM. Within the reference interval, the highest bias observed in selected sample testing investigation was +35.3% for IgM; -4.3% for IgG; +12.3% for IgA; -6.9% for C3; -6.6% for C4; and -17.8% for transferrin. Falsely elevated or reduced results could be…https://plainrecords.com/recall/device/z-1664-2023/https://plainrecords.com/recall/device/z-1664-2023/Wed, 07 Jun 2023 00:00:00 +0000Unavailable to calibrate VITROS Chemistry Products VANC Reagent, Generation (GEN) 50, results in delay of testinghttps://plainrecords.com/recall/device/z-1628-2023/https://plainrecords.com/recall/device/z-1628-2023/Wed, 31 May 2023 00:00:00 +0000Potential for both unexpected positive and negative HbA1c results, may result in misdiagnosishttps://plainrecords.com/recall/device/z-1555-2023/https://plainrecords.com/recall/device/z-1555-2023/Wed, 10 May 2023 00:00:00 +0000MicroTip Pack Opener Assembly Potentially Not Removing or Replacing MicroTip Pack Caps on VITROS¿ 5600 and XT 7600 Integrated Systems, results may be delayed results if a pack becomes unusablehttps://plainrecords.com/recall/device/z-1396-2023/https://plainrecords.com/recall/device/z-1396-2023/Wed, 26 Apr 2023 00:00:00 +0000Incorrect Number of Calibrator Levels (2) Set for the VITROS Immunodiagnostics Products Anti-SARS-CoV-2 Total N Antibody Calibrators in Assay Data Disks (ADD), resulting in delayed patients resultshttps://plainrecords.com/recall/device/z-0878-2023/https://plainrecords.com/recall/device/z-0878-2023/Wed, 11 Jan 2023 00:00:00 +0000Lower than expected iPTH patient and Quality Control (QC) results, reported negatively biased iPTH results- an average -12% shift in patient sample resultshttps://plainrecords.com/recall/device/z-0220-2023/https://plainrecords.com/recall/device/z-0220-2023/Wed, 16 Nov 2022 00:00:00 +0000Calibration disk Data Release Version (DRV) 6194 to 6200 contain inappropriate calibration mathematics for VITROS Calibration Kit 9 for calibrating VITROS PHYT Slides, for all lots of slide generation 22 (GEN 22). The erroneous mathematics on the calibration disk prevents the VITROS 250/350 Chemistry System from successfully calibrating, leading to delayed results.https://plainrecords.com/recall/device/z-1675-2022/https://plainrecords.com/recall/device/z-1675-2022/Wed, 14 Sep 2022 00:00:00 +0000Performing a system shutdown on VITROS XT 3400 and VITROS XT 7600 Systems may cause a positive or negative shift in the electrical current supplied to the LED used in conjunction with the Digital Imaging Reflectometer. Potential exists for either a positive or negative shift in results reported by the VITROS System.https://plainrecords.com/recall/device/z-1367-2022/https://plainrecords.com/recall/device/z-1367-2022/Wed, 20 Jul 2022 00:00:00 +0000On-Analyzer Stability (OAS) time, supported for 6 weeks; not 8 weeks as is currently stated in the Instructions For Use (IFU).https://plainrecords.com/recall/device/z-1112-2022/https://plainrecords.com/recall/device/z-1112-2022/Wed, 25 May 2022 00:00:00 +0000Falsely high or delayed patient and QC results may occur due to low end imprecision. VITROS Immunodiagnostic Products FSH, LH and Prol Reagents Low End Imprecision. Low-level quality control (QC) and patient samples at the low end of the Measuring (Reportable) Range when using VITROS FSH, LH and Prol Reagent. Calibration failures, driven by imprecision observed with Calibrator Level 1.https://plainrecords.com/recall/device/z-0735-2022/https://plainrecords.com/recall/device/z-0735-2022/Wed, 16 Mar 2022 00:00:00 +0000The 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 detected and the affected results are not suppressed, clinical impact may include reduced drug dosage, or false positive or false negative results for bloodborne infectious disease assays when sample results are close to the cut-off value.https://plainrecords.com/recall/device/z-0503-2022/https://plainrecords.com/recall/device/z-0503-2022/Wed, 26 Jan 2022 00:00:00 +0000Lower than expected results for VITROS¿ Immunodiagnostic Products TSH Reagent Pack when diluted with VITROS¿ Immunodiagnostic Products High Sample Diluent A Reagent Pack Lot 2190.https://plainrecords.com/recall/device/z-0247-2022/https://plainrecords.com/recall/device/z-0247-2022/Wed, 24 Nov 2021 00:00:00 +0000Ortho Clinical Diagnostics confirmed a complaint that some VITROS Immunodiagnostic Products Anti-HBc IgM Controls Lot 1690 Controls Values booklet contained information for the incorrect product. While the accuracy of patient test results is not affected by this issue, there is a potential for delayed results due to the troubleshooting of Quality Control results.https://plainrecords.com/recall/device/z-0120-2022/https://plainrecords.com/recall/device/z-0120-2022/Wed, 27 Oct 2021 00:00:00 +0000VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Quantitative Controls Outside of Expected Control Range, potential for delayed resultshttps://plainrecords.com/recall/device/z-1688-2021/https://plainrecords.com/recall/device/z-1688-2021/Wed, 02 Jun 2021 00:00:00 +0000Ortho investigated and confirmed the potential for unexpected failed calibration, and condition codes associated with the calibration, when using VITROS SARS-CoV-2 Ag Reagent Pack along with VITROS Immunodiagnostic Products SARS-CoV-2 Ag Calibrator, Lot 20.https://plainrecords.com/recall/device/z-1489-2021/https://plainrecords.com/recall/device/z-1489-2021/Wed, 05 May 2021 00:00:00 +0000Delayed results. Ortho confirmed that two lots of VITROS Black Reference Slides are incorrectly labelled as White Reference Slides. If the customer fails to notice both the product name or the unexpected color of the slides and tries to use Black Reference Slides as White Reference Slides, the Correction Factor test will fail - and the analyzer will not be able to produce results for any assays…https://plainrecords.com/recall/device/z-1295-2021/https://plainrecords.com/recall/device/z-1295-2021/Wed, 31 Mar 2021 00:00:00 +0000Potential total iron-binding capacity (TIBC) results. The VITROS TIBC performance shift will start with the newest Generation (GEN) of VITROS Fe Slides (GEN 26), the potential shift in TIBC patient values of GEN 26 and above will be approximately 80 ug/dL lower across the measuring range than other available GENS of VITROS Fe Slides (GENs 22-25).https://plainrecords.com/recall/device/z-1266-2021/https://plainrecords.com/recall/device/z-1266-2021/Wed, 24 Mar 2021 00:00:00 +0000VITROS Immunodiagnostic Products SARS-CoV-2 Antigen False Reactive Results Associated When Using Remel M4RT Viral Transport Mediahttps://plainrecords.com/recall/device/z-1136-2021/https://plainrecords.com/recall/device/z-1136-2021/Wed, 03 Mar 2021 00:00:00 +0000A deformity affecting a specific lot of VITROS¿ Chemistry Products VersaTips. Deformed VersaTips results may be biased by up to +/-16% for both immunometric and competitive assays.https://plainrecords.com/recall/device/z-0844-2021/https://plainrecords.com/recall/device/z-0844-2021/Wed, 20 Jan 2021 00:00:00 +0000Eltrombopag Interference for VITROS Chemistry Products TP Slides and VITROS XT Chemistry Products ALB-TP Slideshttps://plainrecords.com/recall/device/z-0800-2021/https://plainrecords.com/recall/device/z-0800-2021/Wed, 13 Jan 2021 00:00:00 +0000A software anomaly may cause an aliquoted sample to be labelled as the incorrect sample. This may lead to results being associated with the wrong patient sample and potentially lead to inappropriate intervention with the potential for injury to the patient.https://plainrecords.com/recall/device/z-0770-2021/https://plainrecords.com/recall/device/z-0770-2021/Wed, 13 Jan 2021 00:00:00 +0000VITROS Chemistry Products CKMB Slides Potential for Falsely Elevated Results Due to CK-MM Interference