VITROS Chemistry Products CKMB Slides — Class II medical device recall Z-1931-2020
Terminated recall by Ortho-Clinical Diagnostics, reported 2020-05-20, distributed nationwide. The Spanish and Swedish language versions of the IFU state that the assay can be tested with Plasma which is f
| Recall number | Z-1931-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ortho-Clinical Diagnostics, Rochester, NY, United States |
| Recall initiated | 2020-04-01 |
| Classified | 2020-05-08 |
| Reported by FDA | 2020-05-20 |
| Terminated | 2021-01-19 |
| Distributed | Nationwide (US) |
| Reason classes | potency |
| UPC / GTIN / UDI-DI | 10758750004201 |
Product
VITROS Chemistry Products CKMB Slides, Creatine Kinase MB, Product Code 8001133-90 slides, UDI Number 10758750004201 - Product Usage: The VITROS Chemistry Product Slides are used to measure creatine kinase MB (CK-MB) activity in serum which used to be ordered to detect Myocardial Infarction.
Reason for recall
The Spanish and Swedish language versions of the IFU state that the assay can be tested with Plasma which is false and could result in biased 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-1931-2020. 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.