Hexokinase, Glucose
Clinical Chemistry · 21 CFR 862.1345
Recent MDR events
37,534 adverse event reports on file
- Glucose HK Gen.3Jul 31, 2026MalfunctionRoche Diagnostics1823260-2026-03139
- Glucose HKJul 27, 2026MalfunctionRoche Diagnostics1823260-2026-03002
- ALINITY C GLUCOSE REAGENT KITJul 6, 2026MalfunctionAbbott Gmbh3002809144-2026-00175
- GLUCOSE HKJul 1, 2026MalfunctionRoche Diagnostics1823260-2026-02639
- GLUCOSE HK GEN.3Jun 26, 2026MalfunctionRoche Diagnostics1823260-2026-02549
- GLUCOSE HK GEN.3Jun 5, 2026MalfunctionRoche Diagnostics1823260-2026-02216
- GLUCOSE HKApr 27, 2026MalfunctionRoche Diagnostics1823260-2026-01623
- GLUCOSE HKApr 23, 2026MalfunctionRoche Diagnostics1823260-2026-01558
- GLUCOSE HKApr 3, 2026MalfunctionRoche Diagnostics1823260-2026-01262
- GLUCOSE HKApr 3, 2026MalfunctionRoche Diagnostics1823260-2026-01263
Event type breakdown
Recalls
22 recall events for this product code
- Horiba Instruments IncTerminatedFeb 2, 2016
ABX PENTRA Glucose PAP CP ref. A11A01668 reagent is intended for the quantitative in vitro diagnostic determination of glucose in human serum, plasma and urine
N-Acetylcysteine (NAC) present in the blood of patients treated for paracetamol overdose can interfere with the Trinder reaction that uses hydrogen peroxide catalytic on aminoantipyrine and phenol, and can produce falsely low results with the reagents using the Trinder reaction method.
Z-0740-2016 · View FDA record ↗ - JAS Diagnostics Inc.TerminatedDec 18, 2014
Glucose Hexokinase (Liquid) Reagent
Product is not performing according to specifications. Control 2 does not consistently recover within its assigned range.
Z-0827-2015 · View FDA record ↗ - Mindray DS USA, Inc. d.b.a. Mindray North AmericaTerminatedMar 22, 2013
BS-200 Chemistry Analyzer
An issue has been identified with the BS-200 where clinical chemistry results may be inaccurate.
Z-0977-2013 · View FDA record ↗ - Pointe Scientific, Inc.TerminatedNov 4, 2009
Pointe Scientific Liquid Glucose (HEXO) Reagent Set, Pointe Scientific, Inc, Canton, MI; Catalog #'s G7517-120,G7517-120, G7517-500, and G7517-1L; 8-G7517-120,
There is a loss of linearity. The product fails to maintain linearity specification of 500 mg/dL.
Z-0104-2010 · View FDA record ↗ - Pointe Scientific, Inc.TerminatedOct 31, 2008
Pointe Scientific Liquid Glucose HEX (R1) Reagent Set, Pointe Scientific, Inc, Canton, MI; Catalog # HG420-R1. (Clinical chemistry)
The inability of the product to maintain stated performance specifications through the stated shelf life.
Z-0219-2009 · View FDA record ↗ - Pointe Scientific, Inc.TerminatedOct 31, 2008
Pointe Scientific Liquid Glucose HEX (R2) Reagent Set, Pointe Scientific, Inc, Canton, MI; Catalog # HG420-R2. (Clinical chemistry)
The inability of the product to maintain stated performance specifications through the stated shelf life.
Z-0220-2009 · View FDA record ↗ - Pointe Scientific, Inc.TerminatedOct 31, 2008
Pointe Scientific Liquid Glucose HEX Reagent Set, Pointe Scientific, Inc, Canton, MI; Catalog # HG720-600 and HG920-756. (Clinical chemistry)
The inability of the product to maintain stated performance specifications through the stated shelf life.
Z-0221-2009 · View FDA record ↗ - Pointe Scientific, Inc.TerminatedOct 31, 2008
Pointe Scientific Liquid Glucose (HEXO) Reagent Set, Pointe Scientific, Inc, Canton, MI; Catalog # HG920-1200, HG920-2500 and 12-HG920-144. (Clinical chemistry
The inability of the product to maintain stated performance specifications through the stated shelf life.
Z-0222-2009 · View FDA record ↗ - Pointe Scientific, Inc.TerminatedOct 31, 2008
Glucose (HEX) Hitachi; 3-HG920-L. (Clinical chemistry)
The inability of the product to maintain stated performance specifications through the stated shelf life.
Z-0223-2009 · View FDA record ↗ - Pointe Scientific, Inc.TerminatedOct 31, 2008
Glucose HEX Reagent; HG920-SAM-911. (Clinical chemistry)
The inability of the product to maintain stated performance specifications through the stated shelf life.
Z-0224-2009 · View FDA record ↗
Registered firms
107 firms currently registered for this product code
Siemens Healthcare Diagnostics Inc.
NEWARK, DE, US
Shenzhen Mindray Bio-medical Electronics Co.,ltd
SHENZHEN Guangdong, CN
Randox Laboratories Limited
CRUMLIN, COUNTY ANTRIM Antrim and Newtownabbey, GB
Roche Diagnostics Gmbh
MANNHEIM Baden-Wurttemberg, DE
Horiba Abx Sas
MONTPELLIER Herault, FR
Diamond Diagnostics Inc.
Budapest, HU
Shenzhen Mindray Bio-medical Electronics Co., Ltd.
Shenzhen Guangdong, CN
Sekisui Diagnostics P.e.i. Inc.
CHARLOTTETOWN Prince Edward Island, CA
Sensor Health Products, Inc.
CAMBRIDGE Ontario, CA
Diafarma Ecza Deposu Ve Medikal Dis Ticaret Dis Tic Ltd Sti
Istanbul, TR
Roche Diagnostics International Ltd.
ROTKREUZ Zug, CH
Horiba Instruments Incorporated
Canton, MI, US
Medica Corp.
BEDFORD, MA, US
Stanbio Laboratory
Boerne, TX, US
Horiba Ltd.
KYOTO, JP
510(k) clearances
145 clearances for this product code
- Roche DiagnosticsFeb 12, 2026
K253490 · Glucose HK Gen.3; ONLINE DAT Methadone II; cobas pro integrated solutions
- Abbott IrelandOct 24, 2025
K252357 · Glucose2
- Roche DiagnosticsSep 16, 2022
K220134 · cobas pure integrated solutions, Glucose HK Gen.3, ISE indirect Na for Gen.2, ONLINE DAT Methadone II, Elecsys TSH
- Roche DiagnosticsAug 16, 2019
K191899 · Glucose HK Gen.3, ISE indirect Na for Gen.2, Elecsys TSH, cobas pro integrated solutions
- Abbott LaboratoriesOct 19, 2017
K170316 · ALINITY C GLUCOSE REAGENT KIT, ALINITY C SYSTEM
- ElitechgroupSep 7, 2016
K153644 · ELITech Clinical Systems GLUCOSE HK SL, ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I and ELITROL II
- Diatron U.S., Inc.Jan 14, 2016
K151487 · Diatron Pictus 700 Clinical Chemistry Analyzer, Diatron ISE, Diatron Glucose Hexokinase Method
- Beckman Coulter, Inc.Apr 17, 2014
K131189 · UNICEL DXC SYNCHRON SYSTEMS GLUCOSE REAGENT (GLUH)