Radiometer America recalls

• Aug. 28, 2019ABL90 FLEX Analyzer REF 393090 UDI:05700693930909 Class IISoftware Security; The action is being initiated because of software security vulnerabilities with the firm's analyzer operating system, which may…
• Feb. 13, 2019Product: ABL800 FLEX with Crea… Class IIFrom three incidents in Denmark and Sweden, comparison studies on patient blood samples carried out for quality assurance demonstrated that…
• Jan. 2, 2019ABL800 analyzer… Class IIThe analyzer software may cause a mis-match of patient demographics and test results when a certain sequence of events occur.
• Oct. 10, 2018ABL90 FLEX analyzers with software versions 3.3MR1 or below… Class IIThe ABL90 FLEX can aspirate Cal 2 solution instead of rinse solution, when the following take place: ¿ The analyzer is in ready mode ¿ Operator lifts…
• Dec. 20, 2017ABL800 analyzer with FLEXQ module… Class IIDue to misinterpretation of the barcode by the scanner, when the registration receipt barcode is scanned by the analyzer , a result from a different…
• Oct. 11, 2017AutoCheck5+… Class IIRadiometer has recently become aware that a few of the AUTOCHECK 5+ level 2 ampoules, will give incorrect results for pCO2 and pO2. A defective QC…
• March 22, 2017ABL90 Flex Model #: 393-090 Portable… and 1 more product Class IIReports that the sample type "cord blood" has been changed into the two sample types "cord blood arterial" and "cord blood venous.
• Dec. 28, 2016AQURE System Software Version 2.2.0 Model #: 933-599 UDI: (01)05700699335999(10)2.2.0 Catalog number: 933-599… Class IIDesign error when displaying additional information in the patient view window; error may result in misreading a parameter and its value.
• May 11, 2016TCM CombiM Modules 903-111 Class IIRadiometer America, Inc. is recalling TCM CombiM on rare occasions they may have an error that can cause the alarm to sound higher than the pre-set…
• Feb. 10, 2016AQURE System… Class IIThe AQURE System has a design error regarding sample type in which sample type may be specified for some results and left blank for other results.…
• Aug. 26, 2015Radiometer Fixation Kit N20 for the TCM CombiM monitoring system… Class IIWhen the fixation ring is taken off the paper liner there is a potential for fractions of the paper liner's surface coating to stick to the surface…
• March 25, 2015Crea A and B membranes… Class IINegative drift on QC during in-use lifetime of CREA membranes can be observed.
• Feb. 11, 2015ABL90 FLEX analyzer… Class IIThe ABL90 analyzer does not always use the most recent calibration data to calculate patient results. This can in some cases lead to a biased patient…
• Dec. 31, 2014HemoCue¿ Glucose 201 Microcuvettes… Class IIBatches of HemoCue Glucose 201 Microcuvettes show discoloration and provide results outside the specification at the end of their shelf life, approx.…
• Sept. 17, 2014RADIANCE v… Class II
• March 5, 2014pCO2 D788 Membranes… Class IIRADIOMETER has become aware that some D788 pCO2 membranes can cause biased measurement results on patient results as well as QC results.
• Jan. 29, 2014ABL90 FLEX Analyzer Radiometer Medical ApS… Class IIRADIOMETER become aware that if the ABL90 FLEX is tilted, this may potentially cause a negative bias on sodium (Na+) results.
• Jan. 22, 2014pO2 D999 membrane units… Class IIRADIOMETER became aware that the regarded lot pO2 units 942-042R0971 were produced with inner solution for pCO2 membrane units. This solution is a…
• Oct. 9, 2013Lactate Membrane units for E7077 Electrode Radiometer Medical ApS… Class IIRADIOMETER became aware that some membranes may have enzyme residue on the outer membrane. The enzyme residue may cause an initial negative bias on…
• Aug. 14, 2013TCM4 series Base Units… Class IIRADIOMETER became aware that the TCM4 series Base Unit does not comply with IEC 60601-1 Sub Clause 15B.
• Jan. 2, 2013Qualicheck 1+… Class IIIThe barcode for the ABL77 on the insert incorrectly enters a control range for pH of 7.90-7.95 into the analyzer. The insert correctly states that…
• Aug. 15, 2012The ABL software version 6.12 for the ABL800 analyzer… and 2 more products Class IIA customer has reported an error on an ABL8xx configured to a Hospital Information System using the data transfer protocol HL7 version 2.5. If the…
• Feb. 13, 2012S1827 Crea Calibration solution 1… When the user activates the dosicap (containing the crea additive) and mounts it onto the bottle, the threads will not seal correctly causing…
• Dec. 1, 2011TC pCO2 Electrodes… Transcutaneous pCO2-electrodes were wrongly coded as: pO2 electrode on the hardware plug for the firm's TCM series monitors. This causes the monitor…
• June 16, 2011Ca++ Membrane Units… Based on internal testing and user/customer complaint reports received, the firm determined that wrinkles may arise on the outer membrane of the…
• April 28, 2011ABL90 FLEX Portable Blood Gas Analyzer System… Following the receipt of two (2) reported customer complaints, the firm determined that the current operating software for their ABL 90 Analyzer does…
• Feb. 2, 2011ABL90 FLEX Blood Analyzer Part Number: 393-090… Due to a software error, a patient mix up can occur on the ABL90. If a sample is pre-registered and the sample "fails" the next result will inherit…
• March 5, 2010Reference Electrode Membranes for use with blood gas analyzer ABL 800 FLEX… Analysis of customer data, (for ABL 8X7 customers) has shown that the reference membranes are out of analytical specifications when replaced as…
• July 15, 2009Waste bottles Part Numbers/Article Numbers: 905-590/D512 and 905-802/D513… When removing the waste bottle from the analyzer waste material may leak both from the analyzer and from the waste bottle.
• Dec. 3, 2008ABL7XX Calibration 1 Solution S1720… The firm found that for this particular lot that the barcode, used for entering the characteristics of CAL1 Solution into the analyzer, does not…
• Jan. 18, 2008ABL700 Series analyzer… and 1 more product Reported calibration errors are not displayed on the analyzers parameter bar screen or on the patient results when the calibration number is between…
• Oct. 11, 2007Pump waste tube for blood gas analysis kit… Tube may break. The firm discovered that the yellowish/white tubes used in their blood gas analyzers (ABL800 Flex Series) were manufactured…
• July 24, 2007ABL 700 Series blood gas analyzers equipped with Software Version… and 1 more product Software anomaly. Protein removing program incorporated in the operating software for Versions: V3.833 and V5.24, of the ABL700 and ABL800 Blood Gas…
• July 3, 2007SafeClinitubes… The clinitubes are not able to be filled due to contamination with silicone during production.
• April 6, 2007ABL800 FLEX Series analyzer with FLEXQ module-equipped with software version 5.2 to 5.27 In some situations pre-registered patient data is not reset when leaving the pre-registration mode in the software. This occurs when a Safe Pico…
• Oct. 28, 2006Radiance Data Management System… Incorrect FI02 values: programming issue can cause incorrect values to be transmitted to the LIS when : 1)- The FIO2 result is edited in the manual…
• Aug. 31, 2006D826 Accessory kit for single tcpO2 Electrodes for use with the TCM400 Transcutaneous Monitor (Cutaneous… Excessive Drift-the membrane units of the device cause the electrode to exceed performance standards for drift in the first two or more calibrations
• Aug. 30, 2006TC Monitor… Alarm may be silenced- Rapid switching, on and off, of the TCM4 monitor may cause the built-in acoustical alarm to remain silent when tripped.
• Aug. 29, 2006S1730 Calibration Solution 2… Calibration solution for ABL700 Blood Gas Analyzers is labeled with an incorrect bar code. The bar code identified on the Cal Solution 2 product is…
• Aug. 29, 2006TCM4 Series Monitoring System (Base Unit) 391-876 (affected device) CompactFlash cards: 914-698 (Defective… System shut down-When the TCM Monitor is turned on and the booting process begins, the device stops after the memory count and will not proceed…
• Aug. 29, 2006SafePICO Samplers… Leaking Tip Caps-Tip caps may leak; after air has been expelled from the syringe through the vented safe tip caps.
• Aug. 26, 2006SafeClinitubes… Leaking Capillary Caps- The dimensions and shapes of the capillary caps do not fit the capillary tubes correctly. This can cause the capillary tubes…
• Aug. 26, 2006D7120… QC Bias-a solution used in the manufacturing of the membrane had a different composition which introduces a bias of 20 mpH.
• Aug. 10, 2006Blood Gas and Co-Ox2 Electrolyte & Metabolyte Analyzers… and 1 more product Under certain circumstances, the ABL 700 & 800 Series Blood Gas Analyzers may experience leakage current into the measuring system. Consequently, the…
• Aug. 3, 2006ABL800 Series Blood Gas Analyzer equipped with Software Version 5.21 ABL800 Series Blood Gas Analyzer became inoperable when the 'restore default setup' button was touched.
• Aug. 3, 2006Reference Electrodes for ABL 700/800 Blood Gas Analyzers… and 1 more product Reference electrodes for the firm's ABL 700/800 Blood Gas Analyzers are oversized and will not fit into the instrument.
• Aug. 3, 2006Capillary (end) caps… and 1 more product Capilliary end caps, an accessory for ABL blood gas analyzers, leak blood from capillary tubes during transport.
• Aug. 3, 2006ABL 5 Capillary Adaptor (a connection that fits the capillary tube on to the aspirator on the ABL 5 & BPH 5… The dimensions and shape of the analyzer adaptor do not fit the analyzer tubes or probe, causing air to be aspirated with the blood sample and…
• Aug. 2, 2006D711… The recalled membranes cause the status value of the pH and electrolyte electrodes to be offset causing readings outside of the acceptable range.
• Aug. 2, 2006Blood Gas and Co-Ox Electrolyte & Metabolyte Analyzer… and 1 more product Software defect. pO2 and pCO2 sample test results run on the firm's ABL700/800 Series Blood Gas Analyzers are not being properly flagged during the…
• Aug. 2, 2006Package Insert which accompanies the Hematocrit and Metabolite QUALICHECK LEVEL 2 Quality Control of… The package insert, which accompanied the QC reagents used with ABL blood gas analyzers, referenced incorrect control ranges for Hct (hematocrit)…
• Aug. 1, 2006D 744 Chloride membrane… The CI membrane units generate too low values for status and sensitivity during calibration.
• July 27, 2006Radiance Data Management System Software Version 2.42 (Stand-alone software package) for the Radiance STAT… Software anomaly. Data generated by blood gas equipment did not correlate with data shown in the Radiance Data Management System.
• July 27, 2006Dri-Tek BG-OX Cartridge… Air bubbles may be trapped on or close to the O2 sensor in the pO2 chamber of the cuvettes in cartridges used for blood gas analysis on NPT7…
• July 26, 2006Model #842-326 (pump tube for waste) & Model #842-327 (pump tube for solution)… An increased failure rate was observed with the yellow rubber tubing. The tubing was found to be leaking blood and solutions after distribution.

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