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AMY
RANDOX LABORATORIES LIMITED · Model AY2811 · UDI-DI 05055273200584
CIJ
Prescription
1
510(k) clearances
1
Adverse events
1
Recalls
6
Facilities
Description
The AMY method used on the Dimension® clinical chemistry system is an in vitro diagnostic test intended for the quantitative determination of amylase activity in serum, plasma and urine.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2020-07-10 | RANDOX LABORATORIES, LTD. | Amylase AY3805 batch 480449 and Pancreatic Amylase AY3855 batch 480483 have failed to meet the quoted performance claims prior to expiry on 28th Sept 2020. |
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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.