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FDAMarch 5, 2024device

Clinical Chemistry Calibration Serum (Catalog number Cal2351) that is 20x5ml lyophilized human based serum covering 38 commonly used clinical chemistry tests.

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

The hazard

Randox Laboratories has identified that Inorganic Phosphate in Calibration Serum Level 3, CAL2351 & CAL10388, is running with a negative bias on RX Series instruments compared to other methods.

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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