Recall Z-1593-2024 ยท JIT Calibrator, Secondary
Randox Laboratories Ltd.
Microalbumin Calibrator Series (mALB CAL)-IVD used to calibrate the Microalbumin Assay Catalog Number: MA1567
| Date | Apr 17, 2024 (initiated Jan 31, 2024) |
| Status | Open, Classified |
| Reason | Microalbumin Calibrator Series, MA1567 & MA2426, is running with a negative bias compared to other methods and may misclassify patient results. Users may experience a shift in Quality Control and patient sample recovery of up to +12%. |
| Root cause | Under Investigation by firm |
| Action | Randox Laboratories (Manufacturer) issued Urgent Field Safety Notice on 31 Jan 24 Complaint Reference: REC716 letter via email to Distributors. Distributors will contact the end-users. Letter states reason for recall, health risk and action to take: We have reassigned the target values in the above lot numbers in line with the ERM reference material. Please refer to the table below for the updated calibrator targets. You may experience a shift in Quality Control and patient sample recovery of up to +12%. Please discard all copies of the calibrator Instructions For Use (IFU)s and download the u |
| Quantity | 8 units |
| Distribution | US Nationwide distribution in the states of GA, MA, WV including PR. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.