VITROS 4600 Chemistry System Software For use in the in-vitro… — Class II medical device recall Z-2067-2012
Terminated recall by Ortho-Clinical Diagnostics, reported 2012-08-01, distributed nationwide. software automatically switches the lot when a vancomycin (VANC) or valproic acid (VALP) reagent is depleted o
| Recall number | Z-2067-2012 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ortho-Clinical Diagnostics, Rochester, NY, United States |
| Recall initiated | 2012-05-21 |
| Classified | 2012-07-23 |
| Reported by FDA | 2012-08-01 |
| Terminated | 2018-07-05 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AU, BR, CA, CL, CO, DE, EC, ES, FR, GB, IN, IT, JP, MX, NZ, PA, PT, SG, VE |
| Quantity | 77 |
| Reason classes | software |
Product
VITROS 4600 Chemistry System Software For use in the in-vitro quantitative, semi quantitative, and qualitative measurement of variety of analytes of clinical interest.
Reason for recall
software automatically switches the lot when a vancomycin (VANC) or valproic acid (VALP) reagent is depleted or the operator manually changes the lot in use causing lack of verification of proper quality assessment.
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-2067-2012. 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.