VITROS Immunodiagnostic Products Anti-HBs Calibrators And Reagent — recall 75591
Health Canada — Medical Devices · Canada · 2024-05-30 · Type II
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Reported risk: QuidelOrtho's internal stability testing of VITROS anti-HBs calibrators detected a gradual reduction in calibration signal for calibrator levels 2 and 3 over the shelf life of the product for the specified lots. This reduction in signal may affect the shape of the calibration curve generated during calibration, compared to the calibration curve generated earlier in the product's shelf life. A change in the shape of the calibration curve may cause patient and QC samples tested using the associated VITROS® immunodiagnostic products anti-HBs reagent pack to report results as falsely elevated, potentially causing negative results to report as borderline, and borderline results to report as positive. This issue is detectable by performing QC as results generated will be higher than expected and/or outside the expected limits for QC, depending on the age of the lot and amount of signal reduction experienced in calibrator levels 2 and 3. Recall start date: May 21, 2024
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