VITROS 4600 Chemistry System — Class II medical device recall Z-1742-2015
Terminated recall by Ortho-Clinical Diagnostics, reported 2015-06-17, distributed nationwide. Software anomaly allows testing of multiple assays using a single urine specimen, regardless of the pretreatme
| Recall number | Z-1742-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ortho-Clinical Diagnostics, Rochester, NY, United States |
| Recall initiated | 2015-04-06 |
| Classified | 2015-06-09 |
| Reported by FDA | 2015-06-17 |
| Terminated | 2018-05-25 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BE, BR, CL, DK, ES, FR, GB, HK, IE, IN, IT, MX, PT, RO, SE, TW |
| Reason classes | potency, software |
| UPC / GTIN / UDI-DI | 10758750012343 |
Product
VITROS 4600 Chemistry System, Software Version 3.2 & Below. Automates pre-analytical and post-analytical sample and data management for in vitro diagnostic use.
Reason for recall
Software anomaly allows testing of multiple assays using a single urine specimen, regardless of the pretreatment requirements for each selected assay, potentially leading to biased patient 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-1742-2015. 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.