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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search Show TPLC since Back To Search Results
Device hexokinase, glucose
Regulation Description Glucose test system.
Product CodeCFR
Regulation Number 862.1345
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 1
ABBOTT LABORATORIES
  SUBSTANTIALLY EQUIVALENT 1
BECKMAN COULTER
  SUBSTANTIALLY EQUIVALENT 1
BECKMAN COULTER, INC.
  SUBSTANTIALLY EQUIVALENT 1
ELITECHGROUP
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Mechanical Problem 37
Low Test Results 30
Adverse Event Without Identified Device or Use Problem 18
High Test Results 15
Incorrect Or Inadequate Test Results 8
Probe 4
Non Reproducible Results 3
Valve 2
Pump 2
Spring 1
Contamination of Device Ingredient or Reagent 1
Device Subassembly 1
Incorrect, Inadequate or Imprecise Result or Readings 1
Holder 1
Device Component Or Accessory 1
Washer 1
Screw 1
Total Device Problems 127

Recalls
Manufacturer Recall Class Date Posted
1 Horiba Instruments Inc II Feb-02-2016
2 JAS Diagnostics Inc. II Dec-18-2014
3 Siemens Healthcare Diagnostics, Inc. II May-04-2018

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