Randox Laboratories Ltd.: Medical Device Recall in 2023 - (Recall #: Z-2448-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

Randox Liquid Protein Calibrators-SP CAL-(LIQ)-In vitro diagnostic product used for the calibration of ASO, Complement C3, Complement C4, CRP, Ferritin, Haptoglobin, IgM, Prealbumin, RF and Transferrin assays Catalogue Number: IT2691

Product Classification:

Class II

Date Initiated: July 19, 2023

Date Posted: August 30, 2023

Recall Number: Z-2448-2023

Event ID: 92781

Reason for Recall:

As part of the firm's ongoing quality monitoring (see internal complaint # OCC72574), Randox Laboratories have restandardized Ferritin in Liquid Protein Calibrators, IT2691, to reference material NISBC 19/118. The calibrators lots 2112IT-2116IT, packed into batches 627222, 627224, 634886 and 634887 have been reassigned as part of the restandardization. Following this restandardization, Ferritin results for Quality Control material and patient samples recovered erroneously higher than the targeted calibrator values by approximately +10% across the assay range following.

Status: Ongoing

Product Quantity: 166 units

Code Information:

GTIN: 05055273204032 Batch/ Lot number Expiry Date 590858 28 08 23; 590859 28 08 23; 627222 28Jul 24; 627224 28Jul24; 634886 28Jul24; 634887 28Jul24

Distribution Pattern:

CA, FL, IL, ME, MI, NC, OH, PA,NJ,

Voluntary or Mandated:

Voluntary: Firm initiated