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FDAMarch 25, 2022device

CK MB Calibrator, Catalogue Number CK2393

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

The hazard

Randox have realigned CK-MB Calibrator, CK2393, lot number 4410CK. Calibrating with the new value will cause a positive shift of approximately 6% with both Quality Controls and Patient Samples.

What to do

FDA enforcement status: Terminated

Brands named

randox laboratoriesrandox

UPCs

05055273201451

Recall history

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

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