Recall Z-0752-2024 ยท JIX Calibrator, Multi-Analyte Mixture
Randox Laboratories Ltd.
Calibration Serum Level 3 CAL2351
| Date | Jan 18, 2024 (initiated Nov 20, 2023) |
| Status | Open, Classified |
| Reason | CK Total in Calibration Serum Level 3, CAL2351, is running with a positive bias on RX Series instruments compared to other methods experience a shift in Quality Control and patient sample recovery of up to 13%. |
| Root cause | Under Investigation by firm |
| Action | Randox issued Urgent Medical Device Correction Letter via email to the US and PR Distributors on 11/20/23. Distributors contacted the customer directly. The Letter states reason for recall, health risk and action to take: Action to be taken: " Discuss the contents of this notice with your Medical Director if you have used the RX Series targets for CK Total in the aforementioned lots. " Complete and return the response form, 12187-QA to technical.services@randox.com within five working days. " Please discard all copies of the IFUs and download the latest versions from www.randox.com. If you ha |
| Quantity | 269 kits |
| Distribution | US Nationwide and 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 |