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mALB
RANDOX LABORATORIES LIMITED · Model MA3828 · UDI-DI 05055273204568
DDZ
Prescription
1
510(k) clearances
0
Adverse events
1
Recalls
12
Facilities
Description
A Microalbumin test system is a device intended for the quantitative in vitro determination of Microalbumin concentration in urine
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-01-31 | Randox Laboratories Ltd. | 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 C |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.