medical Class II Updated 2024-01-24

Randox Laboratories Ltd. recalls Calibration Serum Level 3 - IVD For use as a Calibrator in c

Recalled Product

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

Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: GTIN: 05055273200966 Lot/Batch No: 1214UE Exp. Date: 28 Nov 2023
View official government recall

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