Z-1593-2024 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- April 24, 2024
- Initiation Date
- January 31, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 8 units
Product Description
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 Pattern
US Nationwide distribution in the states of GA, MA, WV including PR.
Code Information
GTIN: 05055273204520 (1) Batch/Lot: 619282 / 1094MA-1098MA