Recall Z-0120-2022— Ortho Clinical Diagnostics Inc
Class II · Terminated
Class II FDA medical device recall by Ortho Clinical Diagnostics Inc, initiated 2021-09-10, terminated 2024-02-13. FDA's recall record names no specific 510(k) clearance for this event. Product: VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Quantitative Controls (IVD)- For use in monitoring the performance of the VITROS ECi/ECiQ/3600 Immunodiagnostic Systems and the VITROS 5600/XT 7600 Integrated Systems when used with the VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Quantitative Reagent Pack used in combination with the VITROS Immunodiagnostic Products Anti- SARS-CoV-2 IgG Quantitative Calibrator for the determination of IgG antibodies to SARS-CoV-2. Product Code: 6199966. Reason: VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Quantitative Controls Outside of Expected Control Range, potential for delayed results.
- Recalling firm
- Ortho Clinical Diagnostics Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-09-10
- Terminated
- 2024-02-13
- Firm location
- Raritan, NJ, United States
Product description
VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Quantitative Controls (IVD)- For use in monitoring the performance of the VITROS ECi/ECiQ/3600 Immunodiagnostic Systems and the VITROS 5600/XT 7600 Integrated Systems when used with the VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Quantitative Reagent Pack used in combination with the VITROS Immunodiagnostic Products Anti- SARS-CoV-2 IgG Quantitative Calibrator for the determination of IgG antibodies to SARS-CoV-2. Product Code: 6199966
Reason for recall
VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Quantitative Controls Outside of Expected Control Range, potential for delayed results
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