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FDANovember 20, 2023device

Calibration Serum Level 3 CAL2351

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

The hazard

CK Total in Calibration Serum Level 3, CAL2351, is running with a positive bias on RX Series instruments compared to other methods experience a shift in Quality Control and patient sample recovery of up to 13%.

What to do

FDA enforcement status: Ongoing

Brands named

randox laboratoriesrandox

UPCs

05055273200966

Recall history

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

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