Recall Z-0753-2024 ยท JIX Calibrator, Multi-Analyte Mixture
Randox Laboratories Ltd.
Calibration Serum Level 3 - IVD For use as a Calibrator in clinical chemistry assays Catalog Number: CAL2351
| Date | Jan 18, 2024 (initiated Nov 20, 2023) |
| Status | Open, Classified |
| Reason | 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 |
| Root cause | Under Investigation by firm |
| Action | 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 Technic |
| Quantity | 108 kits |
| Distribution | US Nationwide including Puerto Rico. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K053153 | RANDOX CALIBRATION SERUM Randox Laboratories, Ltd., Jan 13, 2006 |