Ortho-Clinical Diagnostics, Inc. recalls
6 recalls on record · FDA
Every recall we have on record for Ortho-Clinical Diagnostics, Inc., compiled from federal safety data. Check the hazard, the remedy, and how serious each one is, and always confirm on the official notice.
VITROS Immunodiagnostic Products Anti-HBs Quantitative Reagent Pack, Catalog No. 6801925 …
Affected lots may experience increased calibration failures or an increase in falsely elevated results.
QMS Tacrolimus Calibrators, Product code 10015573
Ortho-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.
VITROS XT 3400 Chemistry System Product Code 6844458 Running Software Version 3.8.0
During 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 system. This delay in reporting results could occur during any assay, including which the speed of the result is deemed critical or STAT and could result in a delay of treatment in a patient. Due to the release strategy of this software version, the user could not update the system but a field engineer had to manually install each affected system.
VITROS Immunodiagnostic Products NT-proBNP II Range Verifiers-For in vitro diagnostic use…
May not meet the stability specifications for shelf life outlined in the Instructions For Use (IFU).
VITROS 5600 Integrated System- For use in the in vitro quantitative, semi-quantitative,…
MicroTip 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 unusable
VITROS Chemistry Products VersaTips, Catalog No. 6801715 A VersaTip sales unit is…
The 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.