VITROS Immunodiagnostic Products Anti-SARSCoV- 2 Total N Antibody… — Class II medical device recall Z-1396-2023
Ongoing recall by Ortho-Clinical Diagnostics, Inc., reported 2023-04-26, distributed nationwide. Incorrect Number of Calibrator Levels (2) Set for the VITROS Immunodiagnostics Products Anti-SARS-CoV-2 Total
| Recall number | Z-1396-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ortho-Clinical Diagnostics, Inc., Raritan, NJ, United States |
| Recall initiated | 2023-03-09 |
| Classified | 2023-04-18 |
| Reported by FDA | 2023-04-26 |
| Distributed | Nationwide (US) |
| Quantity | 256 units |
| Reason classes | potency |
| UPC / GTIN / UDI-DI | 10758750034581 |
| Lot numbers | 0230, 0240, 0250 |
Product
VITROS Immunodiagnostic Products Anti-SARSCoV- 2 Total N Antibody Calibrators programmed onto the Assay Data Disks (ADD) Data Release Versions (DRV): DRVs 6213 through 6218 supporting VITROS Calibrators. Product Code: 6199976
Reason for recall
Incorrect Number of Calibrator Levels (2) Set for the VITROS Immunodiagnostics Products Anti-SARS-CoV-2 Total N Antibody Calibrators in Assay Data Disks (ADD), resulting in delayed patients results
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-1396-2023. 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.