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

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%.

Details from the source

Reason for recall: 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%. Distribution: US Nationwide distribution in the states of GA, MA, WV including PR. Quantity: 6 units Lot/code info: GTIN: 05055273204544 (1) Batch/Lot: 602114 /1083MA-1087MA (2) Batch/Lot: 636645 /1108MA-1112MA (3) Batch/Lot: 662429 /1083MA- 1087MA

UPC codes

05055273204544

Source

Official record: FDA (Device enforcement) ↗

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