Recall Z-0753-2024
Randox Laboratories Ltd. · initiated November 20, 2023
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Calibration Serum Level 3 - IVD For use as a Calibrator in clinical chemistry assays Catalog Number: CAL2351
Codes / lots: GTIN: 05055273200966 Lot/Batch No: 1214UE Exp. Date: 28 Nov 2023
Reason for recall
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
FDA-determined cause: Under Investigation by firm
Action taken
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.
Details
- Recall number
- Z-0753-2024
- Initiated
- November 20, 2023
- Posted by FDA
- January 18, 2024
- Product code
- JIX – Calibrator, Multi-Analyte Mixture
- Quantity
- 108 kits
- Distribution
- US Nationwide including Puerto Rico.
- Recalling firm
- Randox Laboratories Ltd., Crumlin, North