VITROS Chemistry Products DAT Performance Verifier IV in vitro… — Class II medical device recall Z-0914-2018
Terminated recall by Ortho-Clinical Diagnostics, reported 2018-03-14, distributed nationwide. This product is not meeting the current storage labeling for unopened VITROS DAT Performance Verifiers causing
| Recall number | Z-0914-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ortho-Clinical Diagnostics, Rochester, NY, United States |
| Recall initiated | 2017-09-22 |
| Classified | 2018-03-06 |
| Reported by FDA | 2018-03-14 |
| Terminated | 2020-08-24 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BM, BR, CA, CL, CO, DE, ES, FR, GB, IN, IT, JP, MX, PA, PL, RU, SG, VE |
| Quantity | 196 |
| Reason classes | labeling |
| Lot numbers | L5619 |
| Model numbers | 6802330 |
Product
VITROS Chemistry Products DAT Performance Verifier IV in vitro diagnostic
Reason for recall
This product is not meeting the current storage labeling for unopened VITROS DAT Performance Verifiers causing customers to obtain lower than expected VITROS BENZ results when using this 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-0914-2018. 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.