VITROS Chemistry Products PHYT Slides — Class II medical device recall Z-0273-2018
Terminated recall by Ortho-Clinical Diagnostics, reported 2018-01-03, distributed in PR. The firm identified the potential for biased results to be generated when processing VITROS PHYT Slide product
| Recall number | Z-0273-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ortho-Clinical Diagnostics, Rochester, NY, United States |
| Recall initiated | 2017-06-12 |
| Classified | 2017-12-22 |
| Reported by FDA | 2018-01-03 |
| Terminated | 2020-08-11 |
| Distributed | PR |
| Countries outside the US | AU, BM, BR, CA, CL, CN, CO, DE, ES, FR, GB, IN, IT, JP, MX, PA, PL, RU, SG, VE |
| Reason classes | potency |
| UPC / GTIN / UDI-DI | 10758750004690 |
| Model numbers | 829, 8671 |
Product
VITROS Chemistry Products PHYT Slides, REF/CATALOG 829 8671, Rx ONLY, IVD; Ortho-Clinical Diagnostics, Inc. For in vitro diagnostic use only. VITROS Chemistry Products PHYT Slides quantitatively measure phenytoin (PHYT) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
Reason for recall
The firm identified the potential for biased results to be generated when processing VITROS PHYT Slide product with citrate plasma specimen samples. The current Instructions for Use (IFU) and Assay Summary Chart state serum, heparin plasma, and citrate plasma as acceptable specimen types for use with the PHYT assay.
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-0273-2018. 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.