Enzymatic Method, Ammonia
Clinical Chemistry · 21 CFR 862.1065
Recent MDR events
51 adverse event reports on file
- AMMONIAJun 22, 2026MalfunctionRoche Diagnostics1823260-2026-02467
- AMMONIA IIJan 22, 2026MalfunctionRoche Diagnostics1823260-2026-00245
- AMMONIA IIOct 20, 2025MalfunctionRoche Diagnostics1823260-2025-04263
- AMMONIA IIAug 14, 2025MalfunctionRoche Diagnostics1823260-2025-02479
- AMMONIA IIApr 4, 2025MalfunctionRoche Diagnostics1823260-2025-01008
- AMMONIA IIMar 17, 2025MalfunctionRoche Diagnostics1823260-2025-00749
- AMMONIA IIMar 4, 2025MalfunctionRoche Diagnostics1823260-2025-00616
- AMMONIA IIFeb 27, 2024MalfunctionRoche Diagnostics1823260-2024-00561
- NH3L2Dec 18, 2023MalfunctionRoche Diagnostics1823260-2023-04086
- NH3L2Dec 18, 2023MalfunctionRoche Diagnostics1823260-2023-04085
Event type breakdown
Recalls
11 recall events for this product code
- Sekisui Diagnostics P.E.I. Inc.TerminatedJan 23, 2017
Sekisui Diagnostics Ammonia L3K Assay; Catalog Number: 293-80-91 and 293-10
Certain lots are showing an atypical decrease in optical density (OD) over time, which may result in an impact to performance at the high end of the linear range.
Z-1078-2017 · View FDA record ↗ - Sentinel CH SpATerminatedOct 26, 2015
Sentinel MULTIGENT Ammonia Ultra Reagent, In-Vitro Diagnostic for ammonia measurement; List Number: LN 6K89-30. Intended for the in vitro quantitative determina
Results for ammonia are below the linear range of the assay for samples that have been collected in sodium or lithium heparin tubes.
Z-0164-2016 · View FDA record ↗ - Beckman Coulter Inc.TerminatedApr 16, 2012
SYNCHRON Ammonia (AMM) Reagent
The Ammonia Reagent lot M808278 may fail calibration or cause a low shift in Quality Control recovery on some SYNCHRON Systems.
Z-1432-2012 · View FDA record ↗ - Thermo Fisher ScientificTerminatedOct 4, 2007
Ammonia Liquid Stable Reagent, Enzymatic Method. Catalog number TR60101. in vitro diagnostic.
Method is susceptible to positive interference from endogenous ALT in patient samples.
Z-0015-2008 · View FDA record ↗ - Siemens Healthcare Diagnostics, Inc.TerminatedUnknown
Dimension Ammonia Flex reagent cartridge / AMM
Siemens Healthcare Diagnostics has determined that Dimension AMM (DF119) flex reagent cartridge lots EB7180, FB7152, BA7194, EA7223, BA7250 do not meet the 60-day calibration interval claim due to reagent instability and results may show an Abnormal Assay.
Z-1140-2017 · View FDA record ↗ - Siemens Healthcare Diagnostics, Inc.TerminatedUnknown
Dimension Vista Ammonia Flex reagent cartridge / AMM
Siemens Healthcare Diagnostics has determined that Dimension Vista AMM (K3119) Flex reagent cartridge flex lots 16187BE, 16225BB, 16265AB do not meet the 60-day calibration interval claim due to reagent instability and results may show an Abnormal Assay.
Z-1141-2017 · View FDA record ↗ - Siemens Healthcare Diagnostics, Inc.TerminatedUnknown
ADVIA Ammonia (AMM) chemistry assay, an in vitro diagnostic device intended to quantitatively measure Ammonia levels in human plasma (heparin or EDTA). Product
Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid may interfere with the drugs sulfasalazine and/or sulfapyridine causing falsely elevated or falsely depressed results.
Z-1646-2018 · View FDA record ↗ - Siemens Healthcare Diagnostics, Inc.TerminatedUnknown
Dimension Ammonia (AMM) assay; (Product Number: DF119/10711991) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid may interfere with the drugs sulfasalazine and/or sulfapyridine causing falsely elevated or falsely depressed results.
Z-1649-2018 · View FDA record ↗ - Siemens Healthcare Diagnostics, Inc.TerminatedUnknown
Dimension Vista Ammonia (AMM) assay (Product Number: K3119/10711992) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid may interfere with the drugs sulfasalazine and/or sulfapyridine causing falsely elevated or falsely depressed results.
Z-1655-2018 · View FDA record ↗ - RANDOX LABORATORIES, LTD.TerminatedUnknown
AM1015 Randox Ammonia (NH3), Enzymatic UV Method
Randox Ammonia reagents are being recalled from the field due to a positive bias of up to 140mol/l being observed on patient samples.
Z-2965-2020 · View FDA record ↗
Registered firms
25 firms currently registered for this product code
Siemens Healthcare Diagnostics Inc.
NEWARK, DE, US
Roche Diagnostics International Ltd.
ROTKREUZ Zug, CH
Fisher Diagnostics
MIDDLETOWN, VA, US
Cliniqa Corporation
San Marcos, CA, US
Siemens Healthcare Diagnostics Inc.
Tarrytown, NY, US
Abbott Laboratories
Lake Forest, IL, US
Sekisui Diagnostics P.e.i. Inc.
CHARLOTTETOWN Prince Edward Island, CA
Sentinel Ch. Spa
MILANO, IT
Roche Diagnostics Gmbh
PENZBERG Bavaria, DE
Beckman Coulter, Inc.
BREA, CA, US
Roche Diagnostics Gmbh
MANNHEIM Baden-Wurttemberg, DE
Abbott Gmbh
Wiesbaden Hesse, DE
Randox Laboratories Limited
CRUMLIN, COUNTY ANTRIM Antrim and Newtownabbey, GB
Diamond Diagnostics Inc.
Budapest, HU
Horiba Instruments Incorporated
Canton, MI, US
Beckman Coulter, Inc.
CARLSBAD, CA, US
High Technology, Inc.
North Attleboro, MA, US
Inpeco Sa
Novazzano Ticino, CH
510(k) clearances
30 clearances for this product code
- Roche Diagnostics Operations (Rdo)Feb 8, 2019
K183517 · Ammonia II
- Siemens Healthcare DiagnosticsMar 7, 2013
K123677 · DIMENSION VISTA; AMMONIA FLEX REAGENT CARTRIDGE (AMM), CHEMISTRY 3 CALIBRATOR (CHEM 3 CAL)
- Siemens Healthcare DiagnosticsFeb 15, 2013
K123320 · DIMENSION AMMONIA FLEX REAGENT CARTRIDGE
- Dade Behring, Inc.Sep 6, 2006
K062316 · DIMENSION VISTA AMMONIA (AMON) FLEX REAGENT CARTRIDGE
- Sentinel Ch. SrlNov 25, 2005
K051114 · SENTINEL AMMONIA ULTRA DIAGNOSTIC ASSAY
- Diagnostic Chemicals , Ltd.Mar 10, 2004
K033921 · AMMONIA-L3K ASSAY, CATALOGUE NUMBER 233-10
- Randox Laboratories, Ltd.May 12, 2003
K030873 · RANDOX AMMONIA
- Bayer Diagnostics Corp.Dec 24, 2002
K023841 · AMMONIA ASSAY FOR THE ADVIA 1650