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Recall Observatory FDA recall evidence

Device product

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

Z-1593-2024

January 31, 2024

Class II

Product summary

Firm
Randox Laboratories Ltd.
Event
Event 94138
Status
Ongoing
Classification
Class II
Quantity
8 units
Official record key
device-enforcement:Z-1593-2024

Official wording

Reason: 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%.

Code information: GTIN: 05055273204520 (1) Batch/Lot: 619282 / 1094MA-1098MA

Distribution pattern: US Nationwide distribution in the states of GA, MA, WV including PR.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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%.