Hexokinase, Glucose
FDA product code CFR · Class II (moderate risk) · 21 CFR 862.1345 · Clinical Chemistry
145510(k) clearances
0PMA approvals
13recalls
Manufacturers
- Em Diagnostic Systems, Inc. 7
- Harleco 6
- Abbott Laboratories 6
- Heraeus Kulzer, Inc. 6
- Roche Diagnostics Corp. 6
- Pointe Scientific, Inc., 4
- Data Medical Associates, Inc. 4
- Medical Analysis Systems, Inc. 3
- Emd Chemicals, Inc. 3
- Sigma Diagnostics, Inc. 3
- Bayer Corp. 3
- Instrumentation Laboratory CO 3
- Horiba Abx 3
- Mallinckrodt Critical Care 2
- Olympus Corp. 2
- Bd Becton Dickinson Vacutainer Systems Preanalytic 2
- Roche Diagnostic Systems, Inc. 2
- King Diagnostics, Inc. 2
- Diagnostic Chemicals, Ltd. (Usa) 2
- Sigma Chemical Co. 2
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253490 | Glucose HK Gen.3; ONLINE DAT Methadone II; cobas pro integrated solutionsCFR · Traditional | Roche Diagnostics | 02/12/2026SE |
| K252357 | Glucose2CFR · Traditional | Abbott Ireland | 10/24/2025SE |
| K220134 | cobas pure integrated solutions, Glucose HK Gen.3, ISE indirect Na for Gen.2, ONLINE DAT…CFR · Traditional | Roche Diagnostics | 09/16/2022SE |
| K191899 | Glucose HK Gen.3, ISE indirect Na for Gen.2, Elecsys TSH, cobas pro integrated solutionsCFR · Traditional | Roche Diagnostics | 08/16/2019SE |
| K170316 | Alinity C Glucose Reagent Kit, Alinity C SystemCFR · Traditional | Abbott Laboratories | 10/19/2017SE |
| K153644 | ELITech Clinical Systems GLUCOSE HK SL, ELITech Clinical Systems ELICAL 2, ELITech…CFR · Traditional | Elitechgroup | 09/07/2016SE |
| K151487 | Diatron Pictus 700 Clinical Chemistry Analyzer, Diatron ISE, Diatron Glucose Hexokinase…CFR · Traditional | Diatron U.S., Inc. | 01/14/2016SE |
| K131189 | Unicel DXC Synchron Systems Glucose Reagent (Gluh)CFR · Traditional | Beckman Coulter, Inc. | 04/17/2014SE |
| K123018 | Ace Alera Clinical Chemistry System, Ace Glucose Reagent, Ace Ion Selective Electrode…CFR · Traditional | Alfa Wassermann Diagnostic Technologies, Inc. | 04/23/2013SE |
| K120681 | Advia Chemistry GLUH_3 ReagentsCFR · Traditional | Siemens Healthcare Diagnostics, Inc. | 05/15/2012SE |
| K120369 | Hitachi Clinical Analyzer S Test Reagent Cartridge Glucose (Glu)CFR · Traditional | Hitachi Chemical Diagnostics, Inc. | 05/10/2012SE |
| K112377 | BS-400 Chemistry Analyzer, CLC 720 Chemistry AnalyzerCFR · Traditional | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 03/23/2012SE |
| K113131 | Liasys 450CFR · Traditional | Ams | 03/08/2012SE |
| K103531 | Prestige 24I; Biolis 24I; MGC 240CFR · Traditional | Tokyo Boeki Medisys, Inc. | 12/01/2011SE |
| K103788 | Pentra C200, Ise Module and Abx Pentra Glucose HK CP ReagentCFR · Traditional | Horiba Abx SAS | 11/08/2011SE |
| K101854 | Advia Chemistry Glucose HEXOKINASE_3 (GLUH_3) Reagent, Models Ref 05001429CFR · Traditional | Siemens Healthcare Diagnostics | 03/07/2011SE |
| K092603 | Cobas Integra Glucose HK Gen 3 AssayCFR · Special | Roche Diagnostics | 12/04/2009SE |
| K090703 | Poly-Chem 90 GlucoseCFR · Traditional | Polymedco, Inc. | 10/20/2009SE |
| K092506 | Easyra Glu-H Reagent, Model 10200CFR · Special | Medica Corp. | 09/16/2009SE |
| K081276 | Abx Pentra Glucose HK CP, Abx Pentra Uric Acid CP, Abx Pentra Urine Control L/HCFR · Traditional | Horiba Abx | 09/12/2008SE |
| K080468 | Liasys with Models LiasysCFR · Traditional | Ams S.R.L. Analyzer Medical System | 07/25/2008SE |
| K080123 | Apolowako HBA1C, Glucose and Analyzer, Models 993-24601, 991-24401 and 993-25201CFR · Traditional | Wako Chemicals USA, Inc. | 07/17/2008SE |
| K072140 | S40 Clinical Analyzer, S Test Bil, S Test Bun, S Test GluCFR · Traditional | Alfa Wassermann Diagnostic Technologies, Inc. | 06/24/2008SE |
| K072018 | BS-200 Chemistry Analyzer, Mode BS-200CFR · Traditional | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 02/01/2008SE |
| K062118 | Pointe 360CFR · Traditional | Pointe Scientific, Inc., | 07/13/2007SE |
| K061879 | Sdi CA480 Clinical Chemistry System; Saturno 300 Clinical Chemistry SystemCFR · Traditional | Hemodiagnostica, LLC | 12/15/2006SE |
| K062239 | Glucose HK New Formulation Test SystemCFR · Special | Roche Diagnostics Corp. | 09/11/2006SE |
| K061048 | Cobas Integra Glucose HK Gen. 3 Test SystemCFR · Special | Roche Diagnostics Corp. | 05/17/2006SE |
| K060383 | GlucoseCFR · Traditional | Abbott Laboratories | 05/05/2006SE |
| K060256 | Unicel DXC 600I Synchron Access Clinical SystemCFR · Special | Beckman Coulter, Inc. | 02/27/2006SE |
| K052007 | Abx Pentra 400 Clinical Chemistry Analyzer (Option: I.S.E. Module)CFR · Traditional | Horiba Abx | 12/16/2005SE |
| K052163 | Advia Ims Glucose AssayCFR · Traditional | Bayer Healthcare, LLC | 10/11/2005SE |
| K042767 | Datapro Clinical Chelistry AnalyzerCFR · Traditional | Thermo Electron Corporation | 04/27/2005SE |
| K041052 | Raichem Glucose UV (Liquid)CFR · Traditional | Hemagen Diagnostics, Inc. | 06/30/2004SE |
| K031135 | Glucose Flex Reagent Cartridge (Gluc)CFR · Traditional | Dade Behring, Inc. | 06/02/2003SE |
| K024281 | Wako L-Type Glucose 2CFR · Traditional | Wako Chemicals USA, Inc. | 02/24/2003SE |
| K023739 | Glucose-Sl-C Assay, Model 257-30CFR · Traditional | Diagnostic Chemicals , Ltd. | 01/17/2003SE |
| K020852 | Poly-Chem GlucoseCFR · Traditional | Polymedco, Inc. | 07/03/2002SE |
| K011963 | Advia 1650 Glucose Hexokinase 11 AssayCFR · Traditional | Bayer Corp. | 11/20/2001SE |
| K012668 | Raichem Glucose UV ReagentCFR · Traditional | Hemagen Diagnostics, Inc. | 10/15/2001SE |
| K011900 | Glucose (Hexokinase)CFR · Traditional | Jas Diagnostics, Inc. | 07/31/2001SE |
| K002199 | Modification to Liquid Glucose (Hexokinase) Reagent SetCFR · Traditional | Pointe Scientific, Inc., | 11/20/2000SE |
| K001403 | Sigma Diagnostics Infinity Glucose Reagent, Models 17-25, 17-100P, 17-500P, 17-2000P…CFR · Traditional | Sigma Diagnostics, Inc. | 08/10/2000SE |
| K000556 | Atac Pak Glucose Reagent and Atac Calibrator KitsCFR · Traditional | Elan Diagnostics | 05/17/2000SE |
| K000102 | Glucose (Hexokinase) Liquid Reagent, Model G518-150CFR · Special | Teco Diagnostics | 02/08/2000SE |
| K990981 | Glucose, Hexokinase (R1), Model GL101-01, Glucose Hexokinase (R2), Model GL101-02CFR · Traditional | A.P. Total Care, Inc. | 05/25/1999SE |
| K984574 | Infinity Glucose ReagentCFR · Traditional | Sigma Diagnostics, Inc. | 02/11/1999SE |
| K980883 | N-Assay Glu-UlCFR · Traditional | Crestat Diagnostics, Inc. | 09/03/1998SE |
| K981185 | GluCFR · Traditional | Abbott Laboratories | 05/07/1998SE |
| K980026 | Glucose (HK) - Incorporating Dynamic Stabilization Technology - (DST)CFR · Traditional | Trace America, Inc. | 03/10/1998SE |
| K970664 | Glucose ReagentCFR · Traditional | Derma Media Lab., Inc. | 08/01/1997SE |
| K971754 | Liquid Glucose (Hexokinase) Reagent SetCFR · Traditional | Pointe Scientific, Inc., | 07/22/1997SE |
| K971467 | Synchron CX Systems Glucose Reagent (Glu)CFR · Traditional | Carolina Liquid Chemistries Corp. | 06/16/1997SE |
| K971276 | Glucometer Encore Qa+ Blood Glucose MeterCFR · Traditional | Bayer Corp. | 06/16/1997SE |
| K964004 | Glucometer Encore Blood Glucose Test StripsCFR · Traditional | Bayer Corp. | 02/10/1997SE |
| K962435 | STC Auto-Lyte Urinary Glucose AssayCFR · Traditional | OraSure Technologies, Inc. | 12/26/1996SE |
| K953210 | Glucose (Hexokinase) KitCFR · Traditional | Randox Laboratories, Ltd. | 10/25/1996SE |
| K961282 | Glucose-Sl Assay, Catalogue No. 235-60CFR · Traditional | Diagnostic Chemicals , Ltd. | 06/21/1996SE |
| K960084 | Hichem Glucose/Hk Reagent KitCFR · Traditional | Hi Chem, Inc. | 04/04/1996SE |
| K953847 | Roche Reagent for GlucoseCFR · Traditional | Roche Diagnostic Systems, Inc. | 02/13/1996SE |
| K952437 | Dma Glucose Hexokinase U.V. ProcedureCFR · Traditional | Data Medical Associates, Inc. | 10/03/1995SE |
| K951058 | Glucometer Encore Qa+ Blood Glucose Meter WorkstationCFR · Traditional | Heraeus Kulzer, Inc. | 06/01/1995SE |
| K945908 | Glucose (HK) Reagent (Procedure NO.16)CFR · Traditional | Sigma Diagnostics, Inc. | 05/08/1995SE |
| K944406 | Olympus Glucose ReagentCFR · Traditional | Olympus America, Inc. | 03/15/1995SE |
| K942963 | Glucose QvetCFR · Traditional | Prisma Systems | 12/29/1994SE |
| K934900 | Glucometer Encore Qa Blood Glucose Meter ModificationCFR · Traditional | Heraeus Kulzer, Inc. | 12/07/1993SE |
| K931402 | Il Test GlucoseCFR · Traditional | Instrumentation Laboratory CO | 10/12/1993SE |
| K931890 | Glucose-Hk TestCFR · Traditional | Em Diagnostic Systems, Inc. | 07/22/1993SE |
| K926361 | Glucometer Encore Qa Blood Glucose MeterCFR · Traditional | Heraeus Kulzer, Inc. | 06/24/1993SE |
| K922811 | Roche Cobas Futura GlucoseCFR · Traditional | Roche Diagnostic Systems, Inc. | 01/27/1993SE |
| K924601 | Olympus Glucose ReagentCFR · Traditional | Olympus Corp. | 12/03/1992SE |
| K924572 | Emds Glucose (Glu-Hk) Test, Item 65415CFR · Traditional | Em Diagnostic Systems, Inc. | 11/25/1992SE |
| K923129 | King Diagnostics Glucose (HK) ReagentCFR · Traditional | King Diagnostics, Inc. | 11/02/1992SE |
| K923018 | Encore Test StripsCFR · Traditional | Heraeus Kulzer, Inc. | 09/23/1992SE |
| K923040 | Miles Urine Glucose MethodCFR · Traditional | Heraeus Kulzer, Inc. | 09/15/1992SE |
| K922232 | Olympus Glucose ReagentCFR · Traditional | Olympus Corp. | 07/16/1992SE |
| K914794 | Technicon Chem 1 Plasma GlucoseCFR · Traditional | Heraeus Kulzer, Inc. | 12/18/1991SE |
| K912808 | Abbott Quick Start Glucose (Glue) Item# 5A15CFR · Traditional | Em Diagnostic Systems, Inc. | 07/30/1991SE |
| K912251 | King Diagnostics Glucose (HK) Reagent Strip TestCFR · Traditional | King Diagnostics, Inc. | 07/18/1991SE |
| K905227 | Glucose (HK) Reagent, UniversalCFR · Traditional | Enzyme Technology, Inc. | 03/11/1991SE |
| K905144 | Eclipse Ica GlucoseCFR · Traditional | Biotope, Inc. | 01/04/1991SE |
| K901122 | Technicon Chem 1 Clinical Analyzer Urine GlucoseCFR · Traditional | Technicon Instruments Corp. | 03/29/1990SE |
| K897160 | Coulter Glucose ReagentCFR · Traditional | Coulter Electronics, Inc. | 03/09/1990SE |
| K896028 | Glucose-Hexokinase Reagents 4470030,050,300,600CFR · Traditional | American Research Products Co. | 11/14/1989SE |
| K894394 | Abbott Spectrum Glucose-Hexokinase ReagentCFR · Traditional | Abbott Laboratories | 10/03/1989SE |
| K894483 | Glucose-Hk Test (Glu-Hk) Item #65415CFR · Traditional | Em Diagnostic Systems, Inc. | 09/07/1989SE |
| K891923 | Amresco Product Number 7426CFR · Traditional | American Research Products Co. | 06/20/1989SE |
| K884736 | Glucose-Hk Test (Gluc-Hk) Item #65665CFR · Traditional | Em Diagnostic Systems, Inc. | 01/03/1989SE |
| K884021 | Emds Glucose (Gluc) Testpacks, No. 67697/95CFR · Traditional | Em Diagnostic Systems, Inc. | 11/10/1988SE |
| K882334 | Abbott Spectrum Simulstat Glucose/Bun ReagentCFR · Traditional | Abbott Laboratories | 08/09/1988SE |
| K880236 | Glucose HexokinaseCFR · Traditional | Tech-Neal Scientific, Inc. | 03/15/1988SE |
| K874846 | Glucose (Hexokinase)CFR · Traditional | Tech-Co, Inc. | 03/03/1988SE |
| K873835 | Glucose-Hk ReagentCFR · Traditional | Intersect Systems, Inc. | 11/24/1987SE |
| K873936 | Modified Paramax Glucose ReagentCFR · Traditional | Baxter Healthcare Corp | 11/23/1987SE |
| K871976 | Multichem Glucose Hexokinase Reagent #S0919CFR · Traditional | Simmler, Inc. | 06/05/1987SE |
| K871456 | Ultra-Violet Glucose Reagent KitCFR · Traditional | Biochemical Trade, Inc. | 04/29/1987SE |
| K863259 | Glucose HK ProcedureCFR · Traditional | Data Medical Associates, Inc. | 09/26/1986SE |
| K861311 | Glucose (Hexokinase) Reagent SetCFR · Traditional | Sterling Diagnostics, Inc. | 04/24/1986SE |
| K860724 | Enzymatic Glucose Reagent (Hexokinase)CFR · Traditional | Trace Scientific , Ltd. | 04/07/1986SE |
| K860625 | Glucose HK-60 Assay Kit Cat. #201-39CFR · Traditional | Diagnostic Chemicals, Ltd. (Usa) | 03/17/1986SE |
| K855153 | Glucose (UV Hexokiase) Reagent SetCFR · Traditional | Technostics Intl. | 01/14/1986SE |
| K853826 | Glucose Hexokinase for Continuous Flow InstrumentsCFR · Traditional | Catachem, Inc. | 09/30/1985SE |
| K853464 | Glucose SR Liquid Stable Reagent SetCFR · Traditional | Medical Analysis Systems, Inc. | 09/04/1985SE |
| K844998 | Glucose(Hexokinase) Reagent SetCFR · Traditional | Sterling Biochemical, Inc. | 01/18/1985SE |
| K843541 | Pda GlucoseCFR · Traditional | Abbott Laboratories | 09/28/1984SE |
| K843150 | Systemate Glucose 67216CFR · Traditional | Em Diagnostic Systems, Inc. | 08/27/1984SE |
| K842510 | Glucose Assay Kit-HexokinaseCFR · Traditional | Diagnostic Chemicals, Ltd. (Usa) | 07/20/1984SE |
| K841555 | Sigma Procedure 16-UVCFR · Traditional | Sigma Chemical Co. | 05/22/1984SE |
| K832872 | Hexokinase, GlucoseCFR · Traditional | Pointe Scientific, Inc., | 10/14/1983SE |
| K831560 | Glucose Hexokinase Diag. KitCFR · Traditional | Sclavo, Inc. | 07/06/1983SE |
| K821868 | Ultrachem E-GluCFR · Traditional | Harleco Diagnostics | 07/08/1982SE |
| K821475 | Ultrachem E-Glu #64976&65040CFR · Traditional | Emd Chemicals, Inc. | 06/25/1982SE |
| K821470 | Ultrachem E-Glu #64976 & 65040CFR · Traditional | Emd Chemicals, Inc. | 06/02/1982SE |
| K821461 | Ultrachem E-Glu, #64976 & 65040CFR · Traditional | Emd Chemicals, Inc. | 06/02/1982SE |
| K812595 | Ultra Chem E-Glu #64976 & 65040CFR · Traditional | Harleco | 09/29/1981SE |
| K812303 | Glucose-Hk System Pack TestCFR · Traditional | Boehringer Mannheim Corp. | 09/01/1981SE |
| K811849 | Eskaflow Test for GlucoseCFR · Traditional | Smithkline Diagnostics, Inc. | 07/15/1981SE |
| K802810 | Hexokinase, GlucoseCFR · Traditional | Beckman Instruments, Inc. | 12/10/1980SE |
| K801456 | F/Ls Mca Application SoftwareCFR · Traditional | Instrumentation Laboratory CO | 10/03/1980SE |
| K801765 | Glucose Reagent(Uv-Hexokinase)CFR · Traditional | Reagents Applications, Inc. | 09/16/1980SE |
| K801297 | Cobas Reagent for Glucose RapidCFR · Traditional | Roche Analytical Instruments, Inc. | 06/30/1980SE |
| K801052 | Data-Zyme Glucose Hexokinase UVCFR · Traditional | Data Medical Associates, Inc. | 05/23/1980SE |
| K801051 | Data-Zyme Glucose Hexokinase ColozimetriCFR · Traditional | Data Medical Associates, Inc. | 05/23/1980SE |
| K792532 | Glucose (Hexokinase) Reagent SetCFR · Traditional | Macomb Chemical Co. | 01/11/1980SE |
| K791760 | Glucose Hexokinase Coil Reagent SystemCFR · Traditional | Fisher Scientific Co., LLC | 09/27/1979SE |
| K790786 | Glucose (HK) ReagentCFR · Traditional | Gilford Diagnostics | 06/15/1979SE |
| K782136 | Glucose Reagent SystemCFR · Traditional | American Monitor Corp. | 01/26/1979SE |
| K781723 | Glucose Hexokinase, Auto KCFR · Traditional | Medical Analysis Systems, Inc. | 11/03/1978SE |
| K780858 | Princeton Biomedix Hexokinase, GlucoseCFR · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 06/22/1978SE |
| K780515 | Ultrachem E-Glu, 300 Series CentrifuchemCFR · Traditional | Harleco | 05/19/1978SE |
| K780072 | Glucose Reagent SetCFR · Traditional | Medical Analysis Systems, Inc. | 02/14/1978SE |
| K780065 | Ultrachem E-Glu, Manual Determ.CFR · Traditional | Harleco | 02/01/1978SE |
| K771464 | Multistat III Glucose TestCFR · Traditional | Instrumentation Laboratory CO | 09/02/1977SE |
| K771384 | Autozyme Immobilized Enzyme CoilCFR · Traditional | Technicon Instruments Corp. | 08/22/1977SE |
| K771311 | Glucose Reagent (Hexohinase)CFR · Traditional | Mallinckrodt Critical Care | 08/03/1977SE |
| K770886 | Auto-Enzymatic Glucose for AnalyzerCFR · Traditional | Harleco | 07/14/1977SE |
| K770844 | Flucose U.V. Test KitCFR · Traditional | Mallinckrodt Critical Care | 07/14/1977SE |
| K770311 | Glucose Reagent, EnzymaticCFR · Traditional | Icn Pharmaceuticals, Inc. | 03/30/1977SE |
| K770229 | Auto-Enzymatic GlucoseCFR · Traditional | Harleco | 03/01/1977SE |
| K770262 | Glucose (Hexokinase) Delta Test AssayCFR · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 02/23/1977SE |
| K761320 | Glucose KitCFR · Traditional | Environmental Chemical Specialties | 01/25/1977SE |
| K761345 | Gluco-Hex TM Reagent KitCFR · Traditional | J.T. Baker Chemical Co. | 01/05/1977SE |
| K761240 | Auto-Enzymatic GlucoseCFR · Traditional | Harleco | 12/29/1976SE |
| K760247 | Glucose Reagent Sys, Sigma Proced. 115CFR · Traditional | Sigma Chemical Co. | 08/26/1976SE |
| K760055 | Reagent, Glucose, Flow-Through AnalyzerCFR · Traditional | Smithkline Diagnostics, Inc. | 08/26/1976SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1658-2018 Class II | Dimension Vista Glucose (GLU) assay; (Product Number: K1039/10445162) (Mfr: Siemens…Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid may… | Siemens Healthcare Diagnostics, Inc. | 06/29/2017Terminated |
| Z-1652-2018 Class II | Dimension Glucose (GLUC) assay (Product Number: DF40/10444973) (Mfr: Siemens Healthcare…Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid may… | Siemens Healthcare Diagnostics, Inc. | 06/29/2017Terminated |
| Z-0740-2016 Class II | ABX PENTRA Glucose PAP CP ref. A11A01668 reagent is intended for the quantitative in…N-Acetylcysteine (NAC) present in the blood of patients treated for paracetamol overdose can interfere with… | Horiba Instruments Inc | 01/11/2016Terminated |
| Z-0827-2015 Class II | Glucose Hexokinase (Liquid) Reagent For the in vitro quantitative determination of…Product is not performing according to specifications. Control 2 does not consistently recover within its… | JAS Diagnostics Inc. | 10/23/2014Terminated |
| Z-0977-2013 Class II | BS-200 Chemistry Analyzer Designed for clinical laboratory use.An issue has been identified with the BS-200 where clinical chemistry results may be inaccurate. | Mindray DS USA, Inc. d.b.a. Mindray North… | 11/28/2012Terminated |
| Z-0104-2010 | Pointe Scientific Liquid Glucose (HEXO) Reagent Set, Pointe Scientific, Inc, Canton, MI…There is a loss of linearity. The product fails to maintain linearity specification of 500 mg/dL. | Pointe Scientific, Inc. | 10/19/2009Terminated |
| Z-0224-2009 | Glucose HEX Reagent; HG920-SAM-911. (Clinical chemistry)The inability of the product to maintain stated performance specifications through the stated shelf life. | Pointe Scientific, Inc. | 09/10/2008Terminated |
| Z-0223-2009 | Glucose (HEX) Hitachi; 3-HG920-L. (Clinical chemistry)The inability of the product to maintain stated performance specifications through the stated shelf life. | Pointe Scientific, Inc. | 09/10/2008Terminated |
| Z-0222-2009 | Pointe Scientific Liquid Glucose (HEXO) Reagent Set, Pointe Scientific, Inc, Canton, MI…The inability of the product to maintain stated performance specifications through the stated shelf life. | Pointe Scientific, Inc. | 09/10/2008Terminated |
| Z-0221-2009 | Pointe Scientific Liquid Glucose HEX Reagent Set, Pointe Scientific, Inc, Canton, MI…The inability of the product to maintain stated performance specifications through the stated shelf life. | Pointe Scientific, Inc. | 09/10/2008Terminated |
| Z-0220-2009 | Pointe Scientific Liquid Glucose HEX (R2) Reagent Set, Pointe Scientific, Inc, Canton…The inability of the product to maintain stated performance specifications through the stated shelf life. | Pointe Scientific, Inc. | 09/10/2008Terminated |
| Z-0219-2009 | Pointe Scientific Liquid Glucose HEX (R1) Reagent Set, Pointe Scientific, Inc, Canton…The inability of the product to maintain stated performance specifications through the stated shelf life. | Pointe Scientific, Inc. | 09/10/2008Terminated |
| Z-2386-2008 | Unicel DxC 600i System and Unicel Dxl 600 Access Immunoassay SystemThe field action was initiated after the firm confirmed reports of premature failure of the waste pump… | Beckman Coulter Inc | 04/03/2008Terminated |