Home › RANDOX LABORATORIES LIMITED › mALB
mALB
RANDOX LABORATORIES LIMITED · Model MA2423 · UDI-DI 05055273204537
DDZ
Prescription
1
510(k) clearances
0
Adverse events
1
Recalls
12
Facilities
Description
The product is intended to be used for the quantitative in vitro determination of Microalbumin 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 |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
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.