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P AMY
RANDOX LABORATORIES LIMITED · Model AY3855 · UDI-DI 05055273200614
JFJ
Prescription
1
510(k) clearances
13
Adverse events
2
Recalls
30
Facilities
Description
A Pancreatic α‑Amylase test system is a device intended for the quantitative in vitro determination of Pancreatic α‑Amylase activity in serum, plasma or 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. |
| 2007-12-03 | Roche Diagnostics Corp. | False Results- The reagent of the LDL-Cholesterol assay shows a carryover effect on the Lipase assay. Results may be falsely elevated by up to 50 units per liter when used on COBA |
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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.