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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device hexokinase, glucose
Product CodeCFR
Regulation Number 862.1345
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT LABORATORIES
  SUBSTANTIALLY EQUIVALENT 1
ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
AMS
  SUBSTANTIALLY EQUIVALENT 1
BECKMAN COULTER, INC.
  SUBSTANTIALLY EQUIVALENT 1
DIATRON US, INC.
  SUBSTANTIALLY EQUIVALENT 1
ELITECHGROUP
  SUBSTANTIALLY EQUIVALENT 1
HITACHI CHEMICAL DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
HORIBA ABX SAS
  SUBSTANTIALLY EQUIVALENT 1
MEDICA CORP.
  SUBSTANTIALLY EQUIVALENT 1
POLYMEDCO, INC.
  SUBSTANTIALLY EQUIVALENT 1
ROCHE DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 3
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS HEALTHCARE DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS HEALTHCARE DIAGNOSTICS INC.
  SUBSTANTIALLY EQUIVALENT 1
TOKYO BOEKI MEDISYS INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 2 2
2015 3 3
2016 1 1
2017 13 13
2018 8 8
2019 10 10
2020 4 4
2021 5 5
2022 3 3
2023 29 29
2024 7 7

Device Problems MDRs with this Device Problem Events in those MDRs
Low Test Results 41 41
High Test Results 22 22
Non Reproducible Results 20 20
Incorrect, Inadequate or Imprecise Result or Readings 5 5
Incorrect Or Inadequate Test Results 4 4
Calibration Problem 1 1
Contamination of Device Ingredient or Reagent 1 1
Incorrect Measurement 1 1
Contamination 1 1
Low Readings 1 1
False Reading From Device Non-Compliance 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 44 44
No Known Impact Or Consequence To Patient 20 20
No Consequences Or Impact To Patient 19 19
No Information 2 2

Recalls
Manufacturer Recall Class Date Posted
1 Horiba Instruments Inc II Feb-02-2016
2 JAS Diagnostics Inc. II Dec-18-2014
3 Mindray DS USA, Inc. d.b.a. Mindray North America II Mar-22-2013
4 Pointe Scientific, Inc. I Nov-04-2009
5 Siemens Healthcare Diagnostics, Inc. II May-04-2018
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