Randox Laboratories Ltd.: Medical Device Recall in 2024 - (Recall #: Z-1369-2024)

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:

Cystatin C Calibrator - In vitro diagnostic (IVD) use in the calibration of the Randox Cystatin C assay on automated analysers Catalog Number: CVS 2699

Product Classification:

Class II

Date Initiated: February 14, 2024

Date Posted: April 3, 2024

Recall Number: Z-1369-2024

Event ID: 94088

Reason for Recall:

Cystatin C Calibrator Series CVS 2699, is running with a negative bias compared to other methods

Status: Ongoing

Product Quantity: 666 units

Code Information:

GTIN: 05055273207439 (1) Batch 600957 Lot 1378CY - 1382CY (2) Batch 621809, 621815 Lot 1403CY - 1407CY (3) Batch 650533 Lot 1414CY - 1418CY

Distribution Pattern:

US Nationwide distribution in the states of CA, IN.

Voluntary or Mandated:

Voluntary: Firm initiated