[Recalled] 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
The product on this page is subject to an official recall. We summarise the regulator's findings and the recommended action.
Recall details
| 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. |
|---|---|
| Brand / manufacturer | Ortho-Clinical Diagnostics |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-1931-2020 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 01 April 2020 |
| EAN / barcode | 10758750004201 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: 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.
This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.
What to do if you own this product
Check whether your unit is affected and follow the authority's guidance before further use.
Read the full official notice →
Related recalls from Ortho-Clinical Diagnostics
This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.