Device product
Microalbumin Calibrator Series (mALB CAL)-IVD to calibrate the Microalbumin Assay Catalog Number: MA2426
Z-1594-2024
Product summary
- Event
- Event 94138
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 6 units
- Official record key
device-enforcement:Z-1594-2024
Official wording
Reason: 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%.
Code information: GTIN: 05055273204544 (1) Batch/Lot: 602114 /1083MA-1087MA (2) Batch/Lot: 636645 /1108MA-1112MA (3) Batch/Lot: 662429 /1083MA- 1087MA
Distribution pattern: US Nationwide distribution in the states of GA, MA, WV including PR.
Derived failure modes
-
Unknown
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%.