VITROS Chemistry Products TP Slides- IVD measure total protein — Class II medical device recall Z-0844-2021
Terminated recall by Ortho Clinical Diagnostics Inc, reported 2021-01-20, distributed nationwide. Eltrombopag Interference for VITROS Chemistry Products TP Slides and VITROS XT Chemistry Products ALB-TP Slide
| Recall number | Z-0844-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ortho Clinical Diagnostics Inc, Raritan, NJ, United States |
| Recall initiated | 2020-12-15 |
| Classified | 2021-01-12 |
| Reported by FDA | 2021-01-20 |
| Terminated | 2021-07-27 |
| Distributed | Nationwide (US) |
| UPC / GTIN / UDI-DI | 10758750004850 |
Product
VITROS Chemistry Products TP Slides- IVD measure total protein (TP) concentration in serum and plasma using VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Systems Product Code: 8392292
Reason for recall
Eltrombopag Interference for VITROS Chemistry Products TP Slides and VITROS XT Chemistry Products ALB-TP 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-0844-2021. 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.