VITROS Chemistry Products HbA1c Reagent Kit- IVD for the quantitative… — Class II medical device recall Z-1628-2023
Ongoing recall by Ortho-Clinical Diagnostics, Inc., reported 2023-05-31, distributed nationwide. Potential for both unexpected positive and negative HbA1c results, may result in misdiagnosis
| Recall number | Z-1628-2023 |
|---|---|
| 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 | 2023-04-17 |
| Classified | 2023-05-24 |
| Reported by FDA | 2023-05-31 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BE, BM, BR, CA, CL, CN, CO, DE, DK, ES, FR, GB, IN, IT, JP, MX, NL, NO, PT, RU, SE, SG |
| Quantity | 23,751 |
| UPC / GTIN / UDI-DI | 10758750030729 |
| Lot numbers | 2023-NOV-25, 2023-SEP-02, 2024-APR-14, 2024-JAN-24, 2024-JUL-18, 2024-OCT-17, 29-9466, 30-9647, 30-9803, 31-9648, 32-9925, 33-1097, 33-1105, 33-1228 |
Product
VITROS Chemistry Products HbA1c Reagent Kit- IVD for the quantitative determination of percent glycated hemoglobin A1c (DCCT/NGSP) and mmol/mol hemoglobin A1c (IFCC) in human whole blood. Product Code: 6842905
Reason for recall
Potential for both unexpected positive and negative HbA1c results, may result in misdiagnosis
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-1628-2023. 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.