VITROS Chemistry Products Calibrator Kit 11 VANC Reagent Generation — Class II medical device recall Z-1664-2023
Ongoing recall by Ortho-Clinical Diagnostics, Inc., reported 2023-06-07, distributed nationwide. Unavailable to calibrate VITROS Chemistry Products VANC Reagent, Generation (GEN) 50, results in delay of test
| Recall number | Z-1664-2023 |
|---|---|
| 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 | 2023-04-14 |
| Classified | 2023-05-30 |
| Reported by FDA | 2023-06-07 |
| Distributed | Nationwide (US) |
| Countries outside the US | BR, CL, CO |
| Quantity | 132 units |
| UPC / GTIN / UDI-DI | 10758750006601 |
| Lot numbers | 1172 |
| Expiration dates | 2023-10-20 |
Product
VITROS Chemistry Products Calibrator Kit 11 VANC Reagent Generation (GEN) 50 with affected Assay Data Disk (ADD) for Data Release Versions (DRVs) 6215 through 6223. In vitro diagnostic -VITROS Chemistry Products Calibrator Kit 11 is used to calibrate the VITROS 5,1 FS/4600 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Systems for the quantitative measurement of vancomycin (VANC). Product Code: 6801696
Reason for recall
Unavailable to calibrate VITROS Chemistry Products VANC Reagent, Generation (GEN) 50, results in delay of testing
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-1664-2023. 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.