FDA-Device2024-04-24Class II
Microalbumin Calibrator Series (mALB CAL)-IVD used to calibrate the Microalbumin Assay Catalog Number: MA1567
Randox Laboratories Ltd.
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%.
Sold states
US Nationwide distribution in the states of GA, MA, WV including PR.
Affected count
8 units
Manufactured in
55 Diamond Road, Crumlin (North), Ireland
Products
Microalbumin Calibrator Series (mALB CAL)-IVD used to calibrate the Microalbumin Assay Catalog Number: MA1567
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1593-2024Don't want to check this manually?
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