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Hexokinase, Glucose
FDA product code CFR · Class 2 · Clinical Chemistry
65
Registered devices
37,534
Adverse events
22
Recalls
145
510(k) clearances
Devices with this code
CLC480 Chemistry Analyzer W/ISE — CAROLINA LIQUID CHEMISTRIES CORPORATIONARCHITECT — Abbott GmbHABX PENTRA GLUCOSE PAP CP — HORIBA ABX SASGlucose Liqui-UV® — STANBIO LABORATORY, L.P.Pointe Glucose Reagent — HORIBA INSTRUMENTS INCORPORATEDABX PENTRA GLUCOSE HK CP — HORIBA ABX SASGlucose HK — Roche Diagnostics GmbHACE — ALFA WASSERMANN, INC.CAROLINA LIQUID CHEMISTRIES CORP.® GLU REAGENT PRODUCT NO. DT208 — CAROLINA LIQUID CHEMISTRIES CORPORATIONGlucose HK — Roche Diagnostics GmbHGlucose UV REAGENT — CLINIQA CORPORATIONCAROLINA LIQUID CHEMISTRIES CORP.® CLC720 GLU RGT KIT Product No. ST208 — CAROLINA LIQUID CHEMISTRIES CORPORATIONARCHITECT — ABBOTT LABORATORIESGENCHEM™ Glucose Reagent — GENCHEM INCGLUC-HK — RANDOX LABORATORIES LIMITEDGLUCOSE-SL — SEKISUI DIAGNOSTICS, LLCAU — Beckman Coulter, Inc.GLUC-HK — RANDOX LABORATORIES LIMITEDGlucoquant GlucoseHK — Roche Diagnostics GmbHTeco Diagnostics Glucose (Hexokinase) Liquid Reagent — TECO DIAGNOSTICSAtellica CH GluH_3 — Siemens Healthcare Diagnostics Inc.Yumizen C1200 Glucose HK — HORIBA ABX SASGlucose HK Gen3 — Roche Diagnostics GmbHGlucoquant GlucoseHK — Roche Diagnostics GmbH
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2017-06-29 | Siemens Healthcare Diagnostics, Inc. | Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid may interfere with the drugs sulfasalazine and/or sulfapyridine |
| 2017-06-29 | Siemens Healthcare Diagnostics, Inc. | Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid may interfere with the drugs sulfasalazine and/or sulfapyridine |
| 2016-01-11 | Horiba Instruments Inc | N-Acetylcysteine (NAC) present in the blood of patients treated for paracetamol overdose can interfere with the Trinder reaction that uses hydrogen peroxide cat |
| 2014-10-23 | JAS Diagnostics Inc. | Product is not performing according to specifications. Control 2 does not consistently recover within its assigned range. |
| 2012-11-28 | Mindray DS USA, Inc. d.b.a. Mindray North America | An issue has been identified with the BS-200 where clinical chemistry results may be inaccurate. |
| 2009-10-19 | Pointe Scientific, Inc. | There is a loss of linearity. The product fails to maintain linearity specification of 500 mg/dL. |
| 2008-09-10 | Pointe Scientific, Inc. | The inability of the product to maintain stated performance specifications through the stated shelf life. |
| 2008-09-10 | Pointe Scientific, Inc. | The inability of the product to maintain stated performance specifications through the stated shelf life. |
| 2008-09-10 | Pointe Scientific, Inc. | The inability of the product to maintain stated performance specifications through the stated shelf life. |
| 2008-09-10 | Pointe Scientific, Inc. | The inability of the product to maintain stated performance specifications through the stated shelf life. |
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