Randox Laboratories Ltd. recalls Calibration Serum Level 3 - IVD For use as a Calibrator in clinical chemistry assays Catalog Number: CAL2351

Recalled January 24, 2024 · FDA recall Z-0753-2024 · Randox Laboratories

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 · FDA Class II

Units

108 kits

Sold at

US Nationwide including Puerto Rico.

Description

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

Product

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

Manufacturer(s)

Randox Laboratories Ltd.

Made in

Ireland

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →