VITROS Chemistry Products UPRO Slides — Class II medical device recall Z-1179-2017
Terminated recall by Ortho-Clinical Diagnostics, reported 2017-02-15, distributed nationwide. There is a potential for variable negatively and positively biased urine protein results using VITROS UPRO Sli
| Recall number | Z-1179-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ortho-Clinical Diagnostics, Rochester, NY, United States |
| Recall initiated | 2016-12-08 |
| Classified | 2017-02-09 |
| Reported by FDA | 2017-02-15 |
| Terminated | 2018-06-22 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BM, CA, CL, CN, CO, DE, ES, FR, GB, IN, IT, JP, MX, PA, PL, SG, VE |
| UPC / GTIN / UDI-DI | 10758750000593 |
| Model numbers | 0120, 680 |
Product
VITROS Chemistry Products UPRO Slides, UPN 10758750000593, Product Usage: Quantitative measurement of total protein concentration in urine.
Reason for recall
There is a potential for variable negatively and positively biased urine protein results using VITROS UPRO Slides.
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-1179-2017. 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.