FDA recall Z-1593-2024

Product

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

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.

Key facts

Status

Ongoing

Initiation date

2024-01-31

Report date

2024-04-24

Voluntary/Mandated

Voluntary: Firm initiated

Location

Crumlin (North), Ireland

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1593-2024