VITROS 350 Chemistry System — Class II medical device recall Z-2177-2019
Terminated recall by Ortho Clinical Diagnostics, reported 2019-08-14, distributed nationwide. Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System
| Recall number | Z-2177-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ortho Clinical Diagnostics, Rochester, NY, United States |
| Recall initiated | 2019-07-08 |
| Classified | 2019-08-06 |
| Reported by FDA | 2019-08-14 |
| Terminated | 2023-10-19 |
| Distributed | Nationwide (US) |
| Countries outside the US | BR, CA, CL, FR, IN, PH |
| Quantity | 30 |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 10758750002054 |
Product
VITROS 350 Chemistry System, clinical chemistry analyzer
Reason for recall
Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System
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-2177-2019. 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.