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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 system, test, blood glucose, over the counter
Regulation Description Glucose test system.
Product CodeNBW
Regulation Number 862.1345
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 5
ABBOTT LABORATORIES
  SUBSTANTIALLY EQUIVALENT 5
ACON LABORATORIES
  SUBSTANTIALLY EQUIVALENT 1
ACON LABORATORIES, INC.
  SUBSTANTIALLY EQUIVALENT 5
AGAMATRIX, INC.
  SUBSTANTIALLY EQUIVALENT 2
ALL MEDICUS CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
ALLIANCE INTERNATIONAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ANDON HEALTH CO.,LTD
  SUBSTANTIALLY EQUIVALENT 6
APEX BIOTECHNOLOGY CORP.
  SUBSTANTIALLY EQUIVALENT 4
APPLIED BIOMEDICAL LLC
  SUBSTANTIALLY EQUIVALENT 1
ARKRAY, INC.
  SUBSTANTIALLY EQUIVALENT 2
ASCENSIA DIABETES CARE
  SUBSTANTIALLY EQUIVALENT 2
ASCENSIA DIABETES CARE HOLDINGS AG
  SUBSTANTIALLY EQUIVALENT 2
BAYER
  SUBSTANTIALLY EQUIVALENT 1
BAYER HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 1
BIOLAND
  SUBSTANTIALLY EQUIVALENT 1
BIOLAND TECHNOLOGY LTD.
  SUBSTANTIALLY EQUIVALENT 1
BIONIME COPORATION
  SUBSTANTIALLY EQUIVALENT 2
BIONIME CORPORATION
  SUBSTANTIALLY EQUIVALENT 5
BIOTEST MEDICAL CORP.
  SUBSTANTIALLY EQUIVALENT 1
BIOTEST MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
ENTRA HEALTH SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
EPS BIO TECHNOLOGY CORP.
  SUBSTANTIALLY EQUIVALENT 2
HMD BIOMEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
INTUITY MEDICAL, INC
  SUBSTANTIALLY EQUIVALENT 1
I-SENS, INC.
  SUBSTANTIALLY EQUIVALENT 9
JOINSOON MEDICAL TECHNOLOGY CO, LTD.
  SUBSTANTIALLY EQUIVALENT 1
LABSTYLE INNOVATIONS LTD.
  SUBSTANTIALLY EQUIVALENT 1
LIFESCAN EUROPE
  SUBSTANTIALLY EQUIVALENT 2
NOVA
  SUBSTANTIALLY EQUIVALENT 2
NOVA BIOMEDICAL CORP.
  SUBSTANTIALLY EQUIVALENT 2
OK BIOTECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 5
OSANG HEALTHCARE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
POLYMER TECHNOLOGY SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ROCHE DIABETES CARE, INC.
  SUBSTANTIALLY EQUIVALENT 1
ROCHE DIAGNOSTICS CORP.
  SUBSTANTIALLY EQUIVALENT 1
ROCHE DIAGNOSTICS OPERATIONS, INC
  SUBSTANTIALLY EQUIVALENT 1
SD BIOSENSOR, INC.
  SUBSTANTIALLY EQUIVALENT 4
TAIDOC TECHNOLOGY CORPORATION
  SUBSTANTIALLY EQUIVALENT 7
TIANJIN EMPECS MEDICAL DEVICE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
TRIVIDIA HEALTH, INC.
  SUBSTANTIALLY EQUIVALENT 1
TYSON BIORESEARCH, INC.
  SUBSTANTIALLY EQUIVALENT 3

Device Problems
Failure to Power Up 25914
Device Displays Incorrect Message 25289
Incorrect Or Inadequate Test Results 13162
Incorrect, Inadequate or Imprecise Result or Readings 10173
High Test Results 6007
Loss of Power 5383
Device Alarm System 3382
Low Test Results 2637
Appropriate Term/Code Not Available 2138
No Display / Image 2108
Low Battery 1827
Battery Problem 1384
High Readings 1133
Device Operational Issue 1062
Device Damaged Prior to Use 1044
Adverse Event Without Identified Device or Use Problem 869
Insufficient Information 864
Component Missing 762
Device Operates Differently Than Expected 613
Display 577
Display Difficult to Read 571
Output Problem 555
Missing Test Results 550
Image Resolution Poor 542
Sticking 480
Incorrect Software Programming Calculations 386
Display or Visual Feedback Problem 385
Device Inoperable 383
Electrical /Electronic Property Problem 357
No Device Output 324
Low Readings 305
Device Handling Problem 305
Unable to Obtain Readings 296
Failure to Calibrate 288
Test Strip 279
Gauges/Meters 248
Defective Component 247
Image Display Error / Artifact 240
Off-Label Use 235
Monitor 234
Application Program Problem: Dose Calculation Error 213
Crack 210
Bent 173
False Reading From Device Non-Compliance 171
Failure to Obtain Sample 163
Material Discolored 148
Break 141
Material Integrity Problem 137
Physical Property Issue 137
Poor Quality Image 132
Failure to Back-Up 122
Labelling, Instructions for Use or Training Problem 111
Inadequate Instructions for Healthcare Professional 101
Device Difficult to Setup or Prepare 99
Improper Device Output 84
Improper or Incorrect Procedure or Method 82
Defective Device 78
Unsealed Device Packaging 72
Incomplete or Missing Packaging 65
Use of Incorrect Control Settings 64
Incorrect Measurement 54
Charging Problem 47
Thermal Decomposition of Device 46
Melted 45
Erratic or Intermittent Display 44
Data Problem 43
Computer Software Problem 39
Device Stops Intermittently 36
Switch, Push Button 36
Inappropriate Audible Prompt / Feedback 32
Loss of Data 31
Packaging Problem 28
Product Quality Problem 28
Computer Operating System Problem 26
Device Ingredient or Reagent Problem 26
Operating System Becomes Nonfunctional 24
Material Opacification 24
Housing 22
Application Program Problem 21
Device Markings / Labelling Problem 20
Calibration Error 19
Communication or Transmission Problem 19
Nonstandard device 18
Contamination During Use 17
Peeled / Delaminated 17
Smoking 17
Self-Activation or Keying 16
Battery 16
Use of Device Problem 15
Screen 14
Manufacturing, Packaging or Shipping Problem 14
Calibration Problem 14
Power Problem 12
Unexpected Therapeutic Results 11
Label 11
Date/Time-Related Software Problem 11
Imprecision 10
No Apparent Adverse Event 10
Device Issue 10
Cut In Material 10
Total Device Problems 116994

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Diabetes Care, Inc. II Feb-28-2020
2 Cambridge Sensors Limited II Aug-22-2019
3 LABSTYLE INNOVATIONS II Oct-31-2019
4 Livongo Health II Apr-29-2016
5 Polymer Technology Systems, Inc. II Jan-21-2020
6 Polymer Technology Systems, Inc. II Dec-26-2019
7 Polymer Technology Systems, Inc. II Apr-28-2018
8 Roche Diabetes Care, Inc. II Feb-05-2020
9 Roche Diabetes Care, Inc. II Dec-30-2019
10 Roche Diabetes Care, Inc. II Sep-30-2019
11 Trividia Health II Sep-23-2016
12 Trividia Health, Inc. II Jun-01-2020

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