Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland Liquid Protein Calibrators. C3 and Haptoglobin liquid protein calibrators used with Randox IgA, IgG, and IgM assays that require sample predilution. 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
Liquid Protein Calibrators. C3 and Haptoglobin liquid protein calibrators used with Randox IgA, IgG, and IgM assays that require sample predilution.
Brand
Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland
Lot Codes / Batch Numbers
Catalog No. IT2691, GTIN 05055273204032, Batch No./Lot No. (Exp. Date): 647343/2154IT-2158IT (03/28/25), 647342/2154IT-2158IT (03/28/25), 634886/2112IT-2116IT (07/28/24), 634887/2112IT-2116IT (07/28/24), 627224/2112IT-2116IT (07/28/24), 627222/2112IT-2116IT (07/28/24)
Products Sold
Catalog No. IT2691; GTIN 05055273204032; Batch No./Lot No. (Exp. Date): 647343/2154IT-2158IT (03/28/25), 647342/2154IT-2158IT (03/28/25), 634886/2112IT-2116IT (07/28/24), 634887/2112IT-2116IT (07/28/24), 627224/2112IT-2116IT (07/28/24), 627222/2112IT-2116IT (07/28/24)
Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland is recalling Liquid Protein Calibrators. C3 and Haptoglobin liquid protein calibrators used with Randox IgA, IgG, due to The firm has realigned C3 and Haptoglobin in Liquid Protein Calibrators, IT2691, to reference material ERM-DA470k/IFCC.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The firm has realigned C3 and Haptoglobin in Liquid Protein Calibrators, IT2691, to reference material ERM-DA470k/IFCC.
Recommended Action
Per FDA guidance
Consignees were sent a MEDICAL DEVICE CORRECTION NOTIFICATION dated 03/06/2024. The notification instructs consignees to review results generated with the affected batches in line with the clinical profile of the patient, discuss the contents of the provided recall notice with the facility's Medical Director, and complete and return the response form to technical.services@randox.com within five working days. The notice should be shared with all customers if product was further distributed and to those who need to be aware within consignee organizations. Consignees with questions should reach out to Randox Technical Services.
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, NJ, OH, OR
Page updated: Jan 10, 2026