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FDAJanuary 31, 2024device

Microalbumin Calibrator Series (mALB CAL)-IVD to calibrate the Microalbumin Assay Catalog Number: MA2426

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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%.

What to do

FDA enforcement status: Ongoing

Brands named

randox laboratoriesrandox

UPCs

05055273204544

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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