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FDAApril 1, 2020device

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.

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Terminated

Brands named

ortho clinical diagnosticsorthoortho clinical

UPCs

10758750004294

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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