Recall Z-1593-2024— Randox Laboratories Ltd.
Class II · Ongoing
Class II FDA medical device recall by Randox Laboratories Ltd., initiated 2024-01-31. FDA's recall record names no specific 510(k) clearance for this event. Product: Microalbumin Calibrator Series (mALB CAL)-IVD used to calibrate the Microalbumin Assay Catalog Number: MA1567. 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%..
- Recalling firm
- Randox Laboratories Ltd.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-01-31
- Firm location
- Crumlin (North), Ireland
Product description
Microalbumin Calibrator Series (mALB CAL)-IVD used to calibrate the Microalbumin Assay Catalog Number: MA1567
Reason for recall
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%.
Data sourced from openFDA. This site is unofficial and independent of the FDA.