VITROS Immunodiagnostic Products-SARS-CoV-2 IgG Calibrator — Class II medical device recall Z-0450-2021
Terminated recall by Ortho Clinical Diagnostics Inc, reported 2020-11-25, distributed nationwide. Elevated sample results signal/cutoff (s/c) values when using eight (8) lots of VITROS immunodiagnostic Produc
| Recall number | Z-0450-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ortho Clinical Diagnostics Inc, Raritan, NJ, United States |
| Recall initiated | 2020-09-30 |
| Classified | 2020-11-13 |
| Reported by FDA | 2020-11-25 |
| Terminated | 2023-12-07 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BR, CL, CN, CO, GB, IN, IT, JP, SG |
| Quantity | 651 units |
| UPC / GTIN / UDI-DI | 10758750033362 |
| Lot numbers | 0165, 0180, 0185, 0190, 0200, 0205, 0220, 0230 |
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 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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0450-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.