VITROS Chemistry Products Performance Verifier II-For in vitro… — Class III medical device recall Z-0471-2021
Ongoing recall by Ortho Clinical Diagnostics Inc, reported 2020-11-25, distributed nationwide. Product instability; biased ALKP values obtained from VITROS Chemistry Products Performance Verifier II Lot Q7
| Recall number | Z-0471-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ortho Clinical Diagnostics Inc, Raritan, NJ, United States |
| Recall initiated | 2020-10-16 |
| Classified | 2020-11-18 |
| Reported by FDA | 2020-11-25 |
| 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, PL, PT, RU, SE, SG |
| UPC / GTIN / UDI-DI | 10758750004577 |
| Lot numbers | Q7692 |
| Expiration dates | 2021-11-01 |
Product
VITROS Chemistry Products Performance Verifier II-For in vitro diagnostic use only.VITROS Chemistry Products Performance Verifier is an assayed control used to monitor performance on VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and the VITROS 5600/XT 7600 Integrated System - Product Code: 8231474
Reason for recall
Product instability; biased ALKP values obtained from VITROS Chemistry Products Performance Verifier II Lot Q7692 when stored unopened at refrigerated temperatures
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-0471-2021. 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.