Randox Laboratories Ltd.: Medical Device Recall in 2024 - (Recall #: Z-0751-2024)

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. CAL 3, REF CAL2351. Human Assayed Multi-Sera Level 2 (HN1530) Human Assayed Multi-Sera Level 3 (HE 1532)

Product Classification:

Class II

Date Initiated: November 13, 2023

Date Posted: January 24, 2024

Recall Number: Z-0751-2024

Event ID: 93602

Reason for Recall:

There have been transcription errors on the Instructions For Use (IFU) of the Calibration Serum Level 3 (CAL2351 lot 1260UE, 1262UE and 1315UE) for target values of Bilirubin and Triglycerides, on the IFU of Human Assayed Multi-Sera Level 2 (HN1530) for TBIC taget value and on IFU of Human Assayed Multi-Sera Level 3 (HE 1532) for Lipase target value.

Status: Ongoing

Product Quantity: N/A

Code Information:

UDI-DI: 05055273200966, lot1260UE, exp. 28 Nov 2024; lot 1262UE, exp. 28 Jan 2025; and lot 1315UE, exp. 28 May 2025

Distribution Pattern:

US Nationwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated