Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland Calibration Serum Level 3 - IVD For use as a Calibrator in clinical chemistry assays Catalog Number: CAL2351 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
Calibration Serum Level 3 - IVD For use as a Calibrator in clinical chemistry assays Catalog Number: CAL2351
Brand
Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland
Lot Codes / Batch Numbers
GTIN: 05055273200966 Lot/Batch No: 1214UE Exp. Date: 28 Nov 2023
Products Sold
GTIN: 05055273200966 Lot/Batch No: 1214UE Exp. Date: 28 Nov 2023
Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland is recalling Calibration Serum Level 3 - IVD For use as a Calibrator in clinical chemistry assays Catalog Number: due to Target for Alkaline Phosphatase (ALP) for the AMP optimized to IFCC 37C method has been mis-assigned for the RX Series instruments by approximately 10. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Target for Alkaline Phosphatase (ALP) for the AMP optimized to IFCC 37C method has been mis-assigned for the RX Series instruments by approximately 10% on Quality Control and patient samples
Recommended Action
Per FDA guidance
Randox issued Urgent Medical Device Correction letter on 11/20/23 to the distribution center within the USA. The US distributor contacted the customer direct via email. Letter states reason for recall, health risk and action to take: Review your calibrator inventory of this lot and assess your laboratories needs for reimbursement for discarded inventory. " 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. If you have any questions or concerns please contact 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 noticePage updated: Jan 10, 2026