VITROS 5 — Class II medical device recall Z-1728-2015
Terminated recall by Ortho-Clinical Diagnostics, reported 2015-06-17, distributed nationwide. Software anomaly regarding urine samples that require acidified pretreatment. The software has allowed urine s
| Recall number | Z-1728-2015 |
|---|---|
| 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 | 2015-06-08 |
| 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 | software |
| UPC / GTIN / UDI-DI | 10758750001132, 10758750001644 |
Product
VITROS 5,1 FS Chemistry System, Software Version 2.8 & Below Automates pre-analytical and post-analytical sample and data management for in vitro diagnostic use. VITROS Urine Assays: VITROS Calcium (Ca), Magnesium (Mg), and Phosphorus (Phos) requires acidification pretreatment prior to urine assay testing.
Reason for recall
Software anomaly regarding urine samples that require acidified pretreatment. The software has allowed urine samples for assays that require acidified pretreatment to be metered from the same sample container as assays that required no pretreatment when the sample was programmed.
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-1728-2015. 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.