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Pancreatic Amylase
SENTINEL CH. SPA · Model A53704 · UDI-DI 08058056680587
JFJ
Prescription
1
510(k) clearances
15
Adverse events
2
Recalls
32
Facilities
Description
The Pancreatic Amylase assay is an in vitro diagnostic test used for the determination on AU480, AU680 and AU5800 automatic analyzers of the pancreatic amylase in serum and plasma by enzymatic colorimetric method. The assay is intended for professional use only.
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.