Recall Z-0450-2021— Ortho Clinical Diagnostics Inc
Class II · Terminated
Class II FDA medical device recall by Ortho Clinical Diagnostics Inc, initiated 2020-09-30, terminated 2023-12-07. FDA's recall record names no specific 510(k) clearance for this event. Product: VITROS Immunodiagnostic Products-SARS-CoV-2 IgG Calibrator - Product Usage: In-Vitro Diagnostic (EUA) an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. Emergency use of this test is limited to authorized laboratories-- Product Code (Unique Identifier): 6199920 (10758750033362). Reason: Elevated sample results signal/cutoff (s/c) values when using eight (8) lots of VITROS immunodiagnostic Products Anti-SARS-CoV-2 IgG Calibrator and decreased signal in one (1) lot of VITROS¿ Immunodiagnostic Products Anti-SARS-CoV-2 IgG Control.
- Recalling firm
- Ortho Clinical Diagnostics Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-09-30
- Terminated
- 2023-12-07
- Firm location
- Raritan, NJ, United States
Product description
VITROS Immunodiagnostic Products-SARS-CoV-2 IgG Calibrator - Product Usage: In-Vitro Diagnostic (EUA) an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. Emergency use of this test is limited to authorized laboratories-- Product Code (Unique Identifier): 6199920 (10758750033362)
Reason for recall
Elevated sample results signal/cutoff (s/c) values when using eight (8) lots of VITROS immunodiagnostic Products Anti-SARS-CoV-2 IgG Calibrator and decreased signal in one (1) lot of VITROS¿ Immunodiagnostic Products Anti-SARS-CoV-2 IgG Control
Data sourced from openFDA. This site is unofficial and independent of the FDA.