Randox Laboratories Ltd.: Medical Device Recall in 2024 - (Recall #: Z-0753-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: November 20, 2023

Date Posted: January 24, 2024

Recall Number: Z-0753-2024

Event ID: 93630

Reason for Recall:

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

Status: Ongoing

Product Quantity: 108 kits

Code Information:

GTIN: 05055273200966 Lot/Batch No: 1214UE Exp. Date: 28 Nov 2023

Distribution Pattern:

US Nationwide including Puerto Rico.

Voluntary or Mandated:

Voluntary: Firm initiated