Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland 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 Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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
Brand
Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland
Lot Codes / Batch Numbers
GTIN: 05055273204032 Batch/ Lot number Expiry Date 590858 28 08 23, 590859 28 08 23, 627222 28Jul 24, 627224 28Jul24, 634886 28Jul24, 634887 28Jul24
Products Sold
GTIN: 05055273204032 Batch/ Lot number Expiry Date 590858 28 08 23; 590859 28 08 23; 627222 28Jul 24; 627224 28Jul24; 634886 28Jul24; 634887 28Jul24
Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland is recalling Randox Liquid Protein Calibrators-SP CAL-(LIQ)-In vitro diagnostic product used for the calibration due to As part of the firm's ongoing quality monitoring (see internal complaint # OCC72574), Randox Laboratories have restandardized Ferritin in Liquid Prot. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
Randox Labs Ltd (Manufacturer) extended recall to the US distributor via Medical Device Correction Letter dated July 19, 2023. The distributor initial contact with customer and follow up contacts via email and telephone. Letter states reason for recall, health risk and action to take: " Review results generated with the affected batches in line with the clinical profile of the patient. " Discuss the contents of this notice with your Medical Director. " Complete and return the response form 12187-QA to technical.services@randox.com within five working days. Transmission of Field Safety Notice: Send a copy of the FSN to all affected customers and to those who need to be aware within your organisation. If you have any questions or concerns please contact Rand ox Technical Services. Any customers using batches 590858 and 590859 for Ferritin, please contact technical.services@randox.com
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
CA, FL, IL, ME, MI, NJ, NC, OH, PA
Page updated: Jan 10, 2026