Randox Laboratories Ltd. recalls Microalbumin Calibrator Series (mALB CAL)-IVD used to calibrate the Microalbumin Assay Catalog Number: MA1567

Recall date

January 31, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1593-2024

FDA classification

Class II

Brand / firm

Randox Laboratories Ltd.

Sold / distributed

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

Why it was recalled

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%.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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