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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 38 38

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
High Test Results 245 245
Mechanical Problem 235 308
Incorrect, Inadequate or Imprecise Result or Readings 210 217
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 44 44
Device Ingredient or Reagent Problem 34 34
Low Test Results 32 32
Non Reproducible Results 25 26
Calibration Problem 21 21
Computer Software Problem 18 18
Fluid/Blood Leak 17 17
Output Problem 16 16
High Readings 15 15
Noise, Audible 13 13
Connection Problem 12 12
Adverse Event Without Identified Device or Use Problem 11 11
Low Readings 10 10
Failure to Align 9 9
Break 9 9
Imprecision 8 8
Obstruction of Flow 8 8
Complete Blockage 7 7
Physical Property Issue 7 7
Occlusion Within Device 7 7
Failure to Calibrate 7 7
No Pressure 6 6
Device Maintenance Issue 6 6
Contamination of Device Ingredient or Reagent 5 5
Bent 5 5
Fitting Problem 4 4
No Apparent Adverse Event 4 4
Incorrect Measurement 4 4
Partial Blockage 4 4
Calibration Error 4 4
Mechanical Jam 4 6
Image Resolution Poor 4 4
Material Integrity Problem 4 4
Loose or Intermittent Connection 3 3
Improper or Incorrect Procedure or Method 3 3
Temperature Problem 3 3
Material Deformation 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 2334 2417
No Clinical Signs, Symptoms or Conditions 92 93
No Consequences Or Impact To Patient 92 92
No Information 18 18
Exposure to Body Fluids 5 5
No Code Available 4 4
Test Result 2 2
Therapeutic Response, Decreased 2 2
Electric Shock 1 1
Contamination, chemical 1 1
Chemical Exposure 1 1
Injury 1 1
No Patient Involvement 1 1
Hyperglycemia 1 1
Missing Value Reason 1 1
Bruise/Contusion 1 1

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