Catalytic Methods, Amylase
Clinical Chemistry · 21 CFR 862.1070
Recent MDR events
13 adverse event reports on file
- ¿-AMYLASE EPS VER.2Jul 1, 2026MalfunctionRoche Diagnostics1823260-2026-02643
- AMYLASE EPS VER.2Jun 29, 2026MalfunctionRoche Diagnostics1823260-2026-02592
- ¿-AMYLASE EPS VER.2Mar 23, 2026MalfunctionRoche Diagnostics1823260-2026-01024
- AMYL GEN.2Jan 22, 2025MalfunctionRoche Diagnostics1823260-2025-00198
- A-AMYLASE EPS VER. 2Aug 7, 2024MalfunctionRoche Diagnostics1823260-2024-02290
- AMYLASESep 19, 2022MalfunctionAbbott Gmbh3002809144-2022-00330
- AMYL GEN.2Apr 21, 2020MalfunctionRoche Diagnostics1823260-2020-01083
- DIMENSION®Apr 12, 2018MalfunctionSiemens Healthcare Diagnostics Inc.2517506-2018-00258
- DIMENSION®Apr 12, 2018MalfunctionSiemens Healthcare Diagnostics Inc.2517506-2018-00260
- COBAS INTEGRA AMMONIA 150Jul 27, 2012MalfunctionRoche Diagnostics1823260-2012-03879
Event type breakdown
Recalls
2 recall events for this product code
- Roche Diagnostics Corp.TerminatedFeb 8, 2008
Roche LIPC Lipase Colorimetric Reagent; Catalog Number: 03029590322. Roche Diagnostics Corp., Indianapolis, IN 46250
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 COBAS INTEGRA 400 or COBAS INTEGRA 400+ analyzers.
Z-0688-2008 · View FDA record ↗ - RANDOX LABORATORIES, LTD.TerminatedUnknown
Pancreatic Amylase AY3855 batch 480483
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.
Z-2924-2020 · View FDA record ↗
Registered firms
57 firms currently registered for this product code
Roche Diagnostics Gmbh
MANNHEIM Baden-Wurttemberg, DE
Siemens Healthcare Diagnostics Inc.
Tarrytown, NY, US
Sanzay Corporation -
Miami Gardens, FL, US
Carolina Liquid Chemistries
Brea, CA, US
Beckman Coulter, Inc.
CARLSBAD, CA, US
Bialex Lab
Wichita Falls, TX, US
Sekisui Diagnostics P.e.i. Inc.
CHARLOTTETOWN Prince Edward Island, CA
Horiba Abx Sas
MONTPELLIER Herault, FR
Abbott Ireland Diagnostics Division
Longford, IE
Roche Diagnostics International Ltd.
ROTKREUZ Zug, CH
Medica Corp.
BEDFORD, MA, US
Siemens Healthcare Diagnostics Inc.
NEWARK, DE, US
Teco Diagnostics
ANAHEIM, CA, US
Diamond Diagnostics Inc.
Budapest, HU
Roche Diagnostics Gmbh
PENZBERG Bavaria, DE
Fisher Diagnostics
MIDDLETOWN, VA, US
Randox Laboratories Limited
CRUMLIN, COUNTY ANTRIM Antrim and Newtownabbey, GB
Wiener Laboratorios S.a.i.c.
ROSARIO Santa Fe, AR
Beckman Coulter, Inc.
BREA, CA, US
510(k) clearances
99 clearances for this product code
- Abbott Ireland Diagnostics DivisionMay 26, 2022
K210633 · Amylase2
- Siemens Healthcare Diagnostics, Inc.Jul 30, 2019
K191454 · Atellica CH Amylase_2 (AMY_2)
- Biosystems S.A.May 2, 2019
K182474 · alpha-AMYLASE DIRECT, alpha-AMYLASE EPS, alpha-AMYLASE PANCREATIC, BILIRUBIN DIRECT, BILIRUBIN TOTAL
- Hitachi Chemical Diagnostics, Inc.Aug 9, 2013
K130685 · HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGES FOR LD AND AMY
- ElitechgroupOct 3, 2012
K122858 · ELTECH CHINICAL SYSTEM AMYLASE SL ELITECH CLINICAL SYSTEMS ELICAL2 ELTECH CLINICAL SYSTEMS ELITROL I AND ELITROL II
- Beckman Coulter, Inc.Oct 16, 2009
K091846 · SYNCHRON SYSTEMS G7 AMYLASE (AMY7) REAGENT WITH MODEL(S) A71607
- Medica Corp.Nov 17, 2008
K080823 · EASYRA AMYLASE, BUN, GLU-H, TRIG, URIC REAGENT
- Thermo Fisher ScientificMay 22, 2007
K070064 · AMYLASE EPS REAGENT