VITROS 5 — Class II medical device recall Z-0651-2019
Terminated recall by Ortho-Clinical Diagnostics, reported 2018-12-26, distributed nationwide. Software anomaly may incorrectly extend the on-analyzer stability time for a loaded VITROS Reagent.
| Recall number | Z-0651-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ortho-Clinical Diagnostics, Rochester, NY, United States |
| Recall initiated | 2018-10-19 |
| Classified | 2018-12-20 |
| Reported by FDA | 2018-12-26 |
| Terminated | 2022-01-24 |
| Distributed | Nationwide (US) |
| Quantity | 1,105 |
| Reason classes | specification failure, software |
| UPC / GTIN / UDI-DI | 10758750001132 |
| Serial numbers | J34000132, J34002322 |
Product
VITROS 5,1 FS Chemistry System, Version 3.0 & below For use in the in vitro quantitative measurement of a variety of analytes of clinical interest in certain biological fluids (depending on the analyte) such as serum, plasma, urine and cerebrospinal fluid.
Reason for recall
Software anomaly may incorrectly extend the on-analyzer stability time for a loaded VITROS Reagent.
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-0651-2019. 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.