Hexokinase, Glucose
FDA adverse event reports and recall history for hexokinase, glucose (product code CFR), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 37,531
- Deaths
- 49
- Injuries
- 5,343
- Malfunctions
- 31,390
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2016-02-02TerminatedUnder Investigation by firm
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 using glucose oxidase method by colorimetry.
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.
- 2014-12-18TerminatedUnder Investigation by firm
Glucose Hexokinase (Liquid) Reagent For the in vitro quantitative determination of Glucose in serum.
Product is not performing according to specifications. Control 2 does not consistently recover within its assigned range.
- 2013-03-22TerminatedDevice Design
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.
- 2009-11-04TerminatedProcess design
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, 8-G7517-500, 3-G7517-L, 7-G7517-500 and 7-G7517-1000. (Clinical chemistry) Pointe Scientific Liquid Glucose (HEXO) is used for the quantitative determination of glucose in serum.
There is a loss of linearity. The product fails to maintain linearity specification of 500 mg/dL.
- 2008-10-31TerminatedProcess control
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.
- 2008-10-31TerminatedProcess control
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.
- 2008-10-31TerminatedProcess control
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.
- 2008-10-31TerminatedProcess control
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.
- 2008-10-31TerminatedProcess control
Glucose (HEX) Hitachi; 3-HG920-L. (Clinical chemistry)
The inability of the product to maintain stated performance specifications through the stated shelf life.
- 2008-10-31TerminatedProcess control
Glucose HEX Reagent; HG920-SAM-911. (Clinical chemistry)
The inability of the product to maintain stated performance specifications through the stated shelf life.
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