Randox Laboratories Ltd.: Medical Device Recall in 2024 - (Recall #: Z-0752-2024)

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 CAL2351

Product Classification:

Class II

Date Initiated: November 20, 2023

Date Posted: January 24, 2024

Recall Number: Z-0752-2024

Event ID: 93612

Reason for Recall:

CK Total in Calibration Serum Level 3, CAL2351, is running with a positive bias on RX Series instruments compared to other methods experience a shift in Quality Control and patient sample recovery of up to 13%.

Status: Ongoing

Product Quantity: 269 kits

Code Information:

GTIN: 05055273200966 Lot Numbers: 1214UE, 1249UE, 1260UE, 1262UE, 1268UE, 1297UE, 1298UE, 1315UE

Distribution Pattern:

US Nationwide and Puerto Rico.

Voluntary or Mandated:

Voluntary: Firm initiated