Class II

Medical Device Recall: Microalbumin Calibrator Series (mALB CAL)-IVD used to calibrate the Microalbumin Assay Catalog Number: MA1567

Randox Laboratories Ltd. · January 31, 2024

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%.

Distribution

US Nationwide distribution in the states of GA, MA, WV including PR.

States Affected

NATIONWIDE

Quantity Affected

8 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-1593-2024

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

Randox Laboratories Ltd. Medical Device Recall: Microalbumin Calibrator Series (mALB CAL)-IVD used to calibrate the Microalbumin Assay Catalog Number: MA1567 | SafeCheck