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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device assay, glycosylated hemoglobin
Product CodeLCP
Regulation Number 864.7470
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT DIAGNOSTICS TECHNOLOGIES AS
  SUBSTANTIALLY EQUIVALENT 1
ABBOTT RAPID DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 1
ALERE TECHNOLOGIES AS
  SUBSTANTIALLY EQUIVALENT 1
ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 2
ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, LLC
  SUBSTANTIALLY EQUIVALENT 1
ASAHI KASEI PHARMA CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
AXIS-SHIELD DIAGNOSTICS, LTD.
  SUBSTANTIALLY EQUIVALENT 1
AXIS-SHIELD POC AS
  SUBSTANTIALLY EQUIVALENT 1
BAYER HEALTHCARE, LLC
  SUBSTANTIALLY EQUIVALENT 1
BECKMAN COULTER, INC
  SUBSTANTIALLY EQUIVALENT 1
BECKMAN COULTER, INC.
  SUBSTANTIALLY EQUIVALENT 2
BIO-RAD LABORATORIES, INC.
  SUBSTANTIALLY EQUIVALENT 2
BIO-RAD LABORATORIES, INC., CLINICAL SYSTEMS DIVIS
  SUBSTANTIALLY EQUIVALENT 3
BIOHERMES CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
CERAGEM INTERNATIONAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
DIAZYME LABORATORIES
  SUBSTANTIALLY EQUIVALENT 3
DRAWBRIDGE HEALTH, INC.
  SUBSTANTIALLY EQUIVALENT 1
EKF-DIAGNOSTIC GMBH
  SUBSTANTIALLY EQUIVALENT 1
HOME ACCESS HEALTH CORP.
  SUBSTANTIALLY EQUIVALENT 1
INFOPIA CO., LTD
  SUBSTANTIALLY EQUIVALENT 3
IXENSOR CO. LTD.
  SUBSTANTIALLY EQUIVALENT 1
IXENSOR CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
JANA CARE, INC
  SUBSTANTIALLY EQUIVALENT 1
MEC DYNAMICS CORP
  SUBSTANTIALLY EQUIVALENT 3
MEDICA CORP.
  SUBSTANTIALLY EQUIVALENT 1
PRIMUS CORPORATION DBA TRINITY BIOTECH
  SUBSTANTIALLY EQUIVALENT 1
QURASENSE
  SUBSTANTIALLY EQUIVALENT 1
ROCHE
  SUBSTANTIALLY EQUIVALENT 1
ROCHE DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 1
ROCHE DIAGNOSTICS OPERATIONS
  SUBSTANTIALLY EQUIVALENT 1
SAKAE CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
SD BIOSENSOR, INC.
  SUBSTANTIALLY EQUIVALENT 1
SEBIA
  SUBSTANTIALLY EQUIVALENT 3
SEPPIM S.A.S.
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS HEALTHCARE DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 2
SIEMENS HEALTHCARE DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS HEATLHCARE DIAGNOSTICS INC
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 1
SKYLA CORPORATION H.S.P.B.
  SUBSTANTIALLY EQUIVALENT 1
TAIDOC TECHNOLOGY CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
TOSOH BIOSCIENCE, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 182 182
2015 64 64
2016 29 29
2017 147 147
2018 1911 1911
2019 114 197
2020 13 13
2021 7 8
2022 8 8
2023 34 34
2024 14 14

Device Problems MDRs with this Device Problem Events in those MDRs
Device Operates Differently Than Expected 629 629
Device Operational Issue 465 465
Device Displays Incorrect Message 442 442
Device Issue 315 315
Mechanical Problem 234 307
High Test Results 231 231
Incorrect, Inadequate or Imprecise Result or Readings 206 213
Incorrect Or Inadequate Test Results 114 114
Nonstandard Device 103 103
Increase in Pressure 95 95
Pressure Problem 72 72
Decrease in Pressure 63 63
Use of Device Problem 60 60
Leak/Splash 43 43
Device Ingredient or Reagent Problem 34 34
Low Test Results 30 30
Calibration Problem 21 21
Non Reproducible Results 19 20
Computer Software Problem 18 18
Fluid/Blood Leak 17 17
High Readings 14 14
Output Problem 14 14
Noise, Audible 13 13
Connection Problem 12 12
Adverse Event Without Identified Device or Use Problem 11 11
Low Readings 9 9
Failure to Align 9 9
Break 9 9
Imprecision 8 8
Obstruction of Flow 8 8
Failure to Calibrate 7 7
Occlusion Within Device 7 7
Complete Blockage 7 7
Physical Property Issue 7 7
No Pressure 6 6
Device Maintenance Issue 6 6
Bent 5 5
Contamination of Device Ingredient or Reagent 5 5
Fitting Problem 4 4
Partial Blockage 4 4
Calibration Error 4 4
Image Resolution Poor 4 4
Mechanical Jam 4 6
Material Integrity Problem 4 4
No Apparent Adverse Event 4 4
Temperature Problem 3 3
Incorrect Measurement 3 3
Loose or Intermittent Connection 3 3
Improper or Incorrect Procedure or Method 3 3
Smoking 2 2
Loss of Data 2 2
Communication or Transmission Problem 2 2
Computer Operating System Problem 2 2
Unintended Ejection 2 2
Fire 2 2
Inaccurate Flow Rate 2 2
Poor Quality Image 2 2
Detachment Of Device Component 2 2
No Display/Image 2 2
Electrical /Electronic Property Problem 2 2
Insufficient Information 2 2
Data Problem 2 2
Inadequate User Interface 2 2
Infusion or Flow Problem 2 2
Issue With Displayed Error Message 2 2
Material Deformation 2 2
Incorrect Error Code 1 1
Device Damaged by Another Device 1 1
Device Sensing Problem 1 1
Filtration Problem 1 1
Human Factors Issue 1 1
Human-Device Interface Problem 1 1
Material Twisted/Bent 1 1
Operating System Becomes Nonfunctional 1 1
Power Problem 1 1
Patient Data Problem 1 1
Missing Test Results 1 1
Fail-Safe Did Not Operate 1 1
Appropriate Term/Code Not Available 1 1
False Device Output 1 1
Display or Visual Feedback Problem 1 1
Contamination 1 1
Application Interface Becomes Non-Functional Or Program Exits Abnormally 1 1
Display Difficult to Read 1 1
Device Reprocessing Problem 1 1
Air Leak 1 1
Device Alarm System 1 1
Misconnection 1 1
Loss of Power 1 1
Failure to Power Up 1 1
Device Difficult to Setup or Prepare 1 1
Delamination 1 1
Detachment of Device or Device Component 1 1
Device Contamination With Biological Material 1 1
Date/Time-Related Software Problem 1 1
Malposition of Device 1 1
Folded 1 1
Blocked Connection 1 1
Sticking 1 1
Inadequate Storage 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 2334 2417
No Consequences Or Impact To Patient 92 92
No Clinical Signs, Symptoms or Conditions 69 70
No Information 18 18
No Code Available 4 4
Exposure to Body Fluids 4 4
Test Result 2 2
Therapeutic Response, Decreased 2 2
Injury 1 1
Contamination, chemical 1 1
Electric Shock 1 1
Chemical Exposure 1 1
No Patient Involvement 1 1
Bruise/Contusion 1 1
Hyperglycemia 1 1
Missing Value Reason 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Bayer Healthcare Llc II Nov-02-2013
2 Beckman Coulter Inc. II May-10-2011
3 Bio-Rad Laboratories Inc III Jul-27-2011
4 Bio-Rad Laboratories Inc II Apr-11-2011
5 Bio-Rad Laboratories Inc II Apr-06-2011
6 Bio-Rad Laboratories Inc III Feb-17-2011
7 Bio-Rad Laboratories Inc II Feb-15-2011
8 Bio-Rad Laboratories Inc II Oct-22-2010
9 Bio-Rad Laboratories Inc II Oct-21-2010
10 Bio-Rad Laboratories Inc II Jun-25-2010
11 Bio-Rad Laboratories Inc III Mar-05-2010
12 Bio-Rad Laboratories Inc II Feb-26-2010
13 Bio-Rad Laboratories Inc II May-19-2009
14 Bio-Rad Laboratories Inc II Mar-24-2009
15 Bio-Rad Laboratories, Inc. II Jan-27-2016
16 Bio-Rad Laboratories, Inc. II Mar-27-2014
17 Bio-Rad Laboratories, Inc. III Feb-10-2014
18 Bio-Rad Laboratories, Inc. III Oct-07-2011
19 Bio-Rad Laboratories, Inc. III Sep-06-2011
20 Bio-Rad Laboratories, Inc., Hercules, CA III Apr-13-2011
21 Heritage Labs International LLC II Jan-11-2012
22 Metrika Inc II Jun-25-2015
23 Polymer Technology Systems II Dec-13-2019
24 Randox Laboratories Ltd. II Dec-22-2017
25 Roche Diagnostics Operations, Inc. II Nov-11-2016
26 Siemens Healthcare Diagnostics II Sep-03-2013
27 Siemens Healthcare Diagnostics, Inc. II Mar-19-2024
28 Siemens Healthcare Diagnostics, Inc. II Apr-14-2022
29 Siemens Healthcare Diagnostics, Inc. II Jul-31-2020
30 Siemens Healthcare Diagnostics, Inc. II Jun-05-2020
31 Siemens Healthcare Diagnostics, Inc. II Aug-30-2016
32 Siemens Healthcare Diagnostics, Inc. II Nov-25-2015
33 Siemens Healthcare Diagnostics, Inc. II Nov-21-2014
34 Siemens Healthcare Diagnostics, Inc. II Oct-24-2014
35 Siemens Healthcare Diagnostics, Inc. II Jan-03-2014
36 Tosoh Bioscience Inc III Dec-13-2018
37 Tosoh Bioscience Inc II Sep-25-2018
38 Tosoh Bioscience Inc II Aug-11-2018
39 Tosoh Bioscience Inc II May-14-2018
40 Tosoh Bioscience, Inc. III Jul-14-2015
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