Microalbumin Calibrator Series (mALB CAL)-IVD to calibrate the Microalbumin Assay Catalog Number: MA2426
Recall
- Recall Number
- Z-1594-2024
- Event Number
- 94138
- Firm
- Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland
- FEI Number
- 1000361607
- Product Code
- DDZ
- Status
- Open, Classified
- Root Cause
- Under Investigation by firm
- Initiated
- January 31, 2024
- Posted
- April 17, 2024
Description
Microalbumin Calibrator Series (mALB CAL)-IVD to calibrate the Microalbumin Assay Catalog Number: MA2426
Microalbumin Calibrator Series, MA1567 & MA2426, is running with a negative bias compared to other method may misclassify patient results. Users may experience a shift in Quality Control and patient sample recovery of up to +12%.
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 updated IFUs from www.randox.com . If further information is required, please contact [email protected] . In line with the restandardisation to the Microalbumin Calibrator Series, we are updating the target and range for the Microalbumin Liquid control, MA1361, lots 1102MA and 1103MA which are present in batch 631698. The updated targets and ranges can be found in the table below. Please discard any copies of the IFU and download the updated version from www.randox.com.
US Nationwide distribution in the states of GA, MA, WV including PR.
6 units