Ortho-Clinical Diagnostics recalls VITROS Chemistry Products CKMB Slides, Creatine Kinase MB, P
Recalled Product
VITROS Chemistry Products CKMB Slides, Creatine Kinase MB, Product Code 805 8232-300 slides, UDI Number 10758750004294 - 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.
Hazard / Issue
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.
Issued by
FDA
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