Recall Z-1931-2020 — 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.
U.S. FDA — Device Enforcement · United States · 2020-04-01 · Class II
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Reported risk: 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.
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