Home › TECO DIAGNOSTICS › AMYLASE REAGENT SET (KINETIC METHOD)
AMYLASE REAGENT SET (KINETIC METHOD)
TECO DIAGNOSTICS · Model A533-60 · UDI-DI 10673486001143
JFJ
Prescription
1
510(k) clearances
15
Adverse events
2
Recalls
32
Facilities
Description
The AMYLASE REAGENT SET (KINETIC METHOD) is used for the quantitative kinetic determination of amylase activity, using manual or automated procedures, in human serum 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. |
| 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 |
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.