VITROS Chemistry Products COCM Reagent — Class II medical device recall Z-0817-2014
Terminated recall by Ortho-Clinical Diagnostics, reported 2014-01-29, distributed nationwide. Inaccurate quality control results.
| Recall number | Z-0817-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ortho-Clinical Diagnostics, Rochester, NY, United States |
| Recall initiated | 2013-10-04 |
| Classified | 2014-01-23 |
| Reported by FDA | 2014-01-29 |
| Terminated | 2018-05-17 |
| Distributed | Nationwide (US) |
| Countries outside the US | CO, DE, ES, FR, GB, IN, IT, JP, MX, PA, SG, VE |
| Quantity | 3,342 units |
| Expiration dates | 2013-11-01, 2014-03-01, 2014-04-01 |
Product
VITROS Chemistry Products COCM Reagent
Reason for recall
Inaccurate quality control 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-0817-2014. 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.