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FDANovember 20, 2023device

Calibration Serum Level 3 - IVD For use as a Calibrator in clinical chemistry assays Catalog Number: CAL2351

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

The hazard

Target for Alkaline Phosphatase (ALP) for the AMP optimized to IFCC 37¿C method has been mis-assigned for the RX Series instruments by approximately 10% on Quality Control and patient samples

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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Calibration Serum Level 3 - IVD For use as a Calibrator in clinical chemistry assays Catalog Number: CAL2351 — Recall Details · AllClear