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

Hazard

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%.

Details from the source

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. Quantity: 8 units Lot/code info: GTIN: 05055273204520 (1) Batch/Lot: 619282 / 1094MA-1098MA

UPC codes

05055273204520

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.