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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device counter, differential cell
Product CodeGKZ
Regulation Number 864.5220
Device Class 2


Premarket Reviews
ManufacturerDecision
  SUBSTANTIALLY EQUIVALENT 1
ABBOTT LABORATORIES
  SUBSTANTIALLY EQUIVALENT 4
AD ASTRA DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ATHELAS INC.
  SUBSTANTIALLY EQUIVALENT 2
BD BIOSCIENCES
  SUBSTANTIALLY EQUIVALENT 2
BECKMAN COULTER
  SE - WITH LIMITATIONS 1
  SUBSTANTIALLY EQUIVALENT 2
BECKMAN COULTER CELLULAR
  SUBSTANTIALLY EQUIVALENT 1
BECKMAN COULTER, INC.
  SUBSTANTIALLY EQUIVALENT 4
BECTON DICKINSON & CO.
  SUBSTANTIALLY EQUIVALENT 1
BOULE MEDICAL AB
  SUBSTANTIALLY EQUIVALENT 1
CHEMPAQ A/S
  SUBSTANTIALLY EQUIVALENT 1
DIATRON US INC
  SUBSTANTIALLY EQUIVALENT 2
HORIBA ABX SAS
  SUBSTANTIALLY EQUIVALENT 3
IMMUDEX APS
  SUBSTANTIALLY EQUIVALENT 1
MICROGENICS CORP.
  SUBSTANTIALLY EQUIVALENT 1
MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
  SUBSTANTIALLY EQUIVALENT 2
NANOENTEK, INC.
  SUBSTANTIALLY EQUIVALENT 4
PIXCELL MEDICAL TECHNOLOGIES, LTD.
  SUBSTANTIALLY EQUIVALENT 2
REAMETRIX INC.
  SUBSTANTIALLY EQUIVALENT 1
ROCHE DIAGNOSTICS HEMATOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 1
S.D. SIGHT DIAGNOSTICS LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS HEALTHCARE DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 3
SIGHT DIAGNOSTICS LTD.
  SUBSTANTIALLY EQUIVALENT 1
SYSMEX AMERICA, INC.
  SUBSTANTIALLY EQUIVALENT 11

MDR Year MDR Reports MDR Events
2014 3113 3113
2015 1972 1972
2016 3338 3338
2017 229 229
2018 497 497
2019 908 908
2020 342 342
2021 391 391
2022 198 198
2023 143 143
2024 31 31

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 2988 2988
Low Test Results 2637 2637
Incorrect, Inadequate or Imprecise Result or Readings 1879 1879
Nonstandard Device 1602 1602
Leak/Splash 1458 1458
Device Displays Incorrect Message 721 721
Device Operates Differently Than Expected 402 402
High Test Results 371 371
Incorrect Or Inadequate Test Results 333 333
Output Problem 223 223
Pressure Problem 110 110
Adverse Event Without Identified Device or Use Problem 99 99
Smoking 80 80
Chemical Spillage 68 68
Thermal Decomposition of Device 48 48
Use of Device Problem 35 35
Air Leak 31 31
Missing Test Results 30 30
Break 25 25
Mechanical Problem 25 25
Device Alarm System 24 24
Device Emits Odor 23 23
Fire 22 22
Improper Device Output 21 21
Appropriate Term/Code Not Available 21 21
Device Handling Problem 21 21
Noise, Audible 19 19
Device Operational Issue 18 18
Low Readings 17 17
Device Inoperable 17 17
Contamination 17 17
Complete Blockage 16 16
Improper or Incorrect Procedure or Method 16 16
Device Markings/Labelling Problem 16 16
Insufficient Information 16 16
Patient Data Problem 15 15
Aspiration Issue 15 15
Disconnection 15 15
Charred 14 14
Crack 13 13
Electrical /Electronic Property Problem 13 13
Sparking 12 12
Data Problem 11 11
Device Issue 9 9
Electrical Shorting 9 9
Temperature Problem 9 9
False Positive Result 9 9
Device Stops Intermittently 9 9
Output above Specifications 8 8
Computer Software Problem 8 8
Intermittent Continuity 7 7
Bent 7 7
Unable to Obtain Readings 7 7
Overfill 7 7
Device Ingredient or Reagent Problem 7 7
Ambient Temperature Problem 6 6
High Readings 6 6
Device Contamination with Body Fluid 6 6
Output below Specifications 6 6
Sticking 6 6
Overheating of Device 6 6
Detachment Of Device Component 6 6
Hole In Material 6 6
Unintended Movement 6 6
Unintended Electrical Shock 5 5
False Reading From Device Non-Compliance 5 5
Display Difficult to Read 5 5
Incorrect Measurement 5 5
Loose or Intermittent Connection 5 5
Device Contamination with Chemical or Other Material 5 5
Defective Component 5 5
Obstruction of Flow 5 5
Contamination of Device Ingredient or Reagent 4 4
Failure of Device to Self-Test 4 4
Therapeutic or Diagnostic Output Failure 4 4
Melted 4 4
Product Quality Problem 4 4
Failure to Power Up 4 4
No Display/Image 4 4
Display or Visual Feedback Problem 4 4
False Device Output 4 4
Missing Information 4 4
Wrong Label 3 3
Excess Flow or Over-Infusion 3 3
Circuit Failure 3 3
Retraction Problem 3 3
Loss of Power 3 3
Positioning Problem 3 3
Mechanical Jam 3 3
Human-Device Interface Problem 3 3
Infusion or Flow Problem 3 3
Maintenance Does Not Comply To Manufacturers Recommendations 3 3
Defective Device 3 3
Failure to Align 3 3
Device Slipped 3 3
Cut In Material 2 2
Split 2 2
Arcing 2 2
Communication or Transmission Problem 2 2
Blocked Connection 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 6257 6257
No Consequences Or Impact To Patient 2330 2330
Not Applicable 1393 1393
No Clinical Signs, Symptoms or Conditions 781 781
No Patient Involvement 196 196
Test Result 85 85
No Code Available 51 51
Needle Stick/Puncture 17 17
Injury 13 13
No Information 13 13
Misdiagnosis 12 12
Eye Injury 9 9
Chemical Exposure 8 8
Exposure to Body Fluids 7 7
Death 5 5
Missing Value Reason 5 5
Electric Shock 3 3
Hemorrhage/Bleeding 3 3
Laceration(s) 3 3
Shock 2 2
Fainting 2 2
Cancer 2 2
Unspecified Blood or Lymphatic problem 2 2
Muscle/Tendon Damage 2 2
Insufficient Information 2 2
Head Injury 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Swelling/ Edema 1 1
Unspecified Eye / Vision Problem 1 1
Lymphoma 1 1
Alteration In Body Temperature 1 1
Blood Loss 1 1
Fracture, Arm 1 1
Reaction 1 1
Excessive Tear Production 1 1
Complaint, Ill-Defined 1 1
Fall 1 1
Fever 1 1
Abdominal Pain 1 1
Anemia 1 1
Aspiration/Inhalation 1 1
Skin Irritation 1 1
Electrolyte Imbalance 1 1
HIV, Human Immunodeficiency Virus 1 1
Pain 1 1
Hyperglycemia 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Diagnostics Division, 5440 Patrick Henry Drive, Santa Clara, CA II Nov-29-2010
2 Abbott Laboratories II Dec-21-2023
3 Abbott Laboratories II Oct-22-2019
4 Abbott Laboratories II Mar-29-2019
5 Abbott Laboratories II Mar-09-2017
6 Abbott Laboratories II Apr-19-2016
7 Abbott Laboratories II Apr-29-2011
8 Abbott Laboratories II Mar-18-2011
9 Abbott Laboratories II Mar-17-2011
10 Abbott Laboratories II Mar-17-2011
11 Abbott Laboratories II Mar-17-2011
12 Abbott Laboratories II Mar-11-2011
13 Abbott Laboratories II Feb-10-2011
14 Abbott Laboratories II Sep-14-2010
15 Abbott Laboratories II Sep-02-2010
16 Abbott Laboratories II May-20-2010
17 Abbott Laboratories II Oct-19-2009
18 Abbott Laboratories II May-22-2009
19 Abbott Laboratories II Apr-23-2009
20 Abbott Laboratories II Apr-10-2009
21 BD Biosciences, Systems & Reagents III Jul-16-2015
22 BD Biosciences, Systems & Reagents III Aug-14-2014
23 BD Biosciences, Systems & Reagents II Sep-17-2012
24 BD Biosciences, Systems & Reagents II Mar-30-2011
25 BD Biosciences, Systems & Reagents II Nov-03-2010
26 BD Biosciences, Systems & Reagents II Jun-30-2010
27 BD Biosciences, Systems & Reagents III Apr-16-2010
28 Beckman Coulter Inc II Jan-13-2009
29 Beckman Coulter Inc II Jan-07-2009
30 Beckman Coulter Inc. I May-23-2019
31 Beckman Coulter Inc. I Nov-20-2018
32 Beckman Coulter Inc. II Dec-13-2017
33 Beckman Coulter Inc. II Sep-07-2017
34 Beckman Coulter Inc. II Sep-01-2017
35 Beckman Coulter Inc. II May-24-2017
36 Beckman Coulter Inc. II Jan-11-2017
37 Beckman Coulter Inc. II Sep-02-2016
38 Beckman Coulter Inc. II Dec-16-2015
39 Beckman Coulter Inc. II Jun-20-2014
40 Beckman Coulter Inc. II Dec-10-2013
41 Beckman Coulter Inc. II Nov-04-2013
42 Beckman Coulter Inc. II Nov-01-2013
43 Beckman Coulter Inc. II Oct-10-2012
44 Beckman Coulter Inc. II Oct-09-2012
45 Beckman Coulter Inc. II Mar-21-2012
46 Beckman Coulter Inc. II Jan-11-2012
47 Beckman Coulter Inc. II Sep-01-2011
48 Beckman Coulter Inc. II May-20-2011
49 Beckman Coulter Inc. II May-10-2011
50 Beckman Coulter Inc. II May-09-2011
51 Beckman Coulter Inc. II May-05-2011
52 Beckman Coulter Inc. II May-05-2011
53 Beckman Coulter Inc. II May-02-2011
54 Beckman Coulter Inc. II Apr-29-2011
55 Beckman Coulter Inc. II Apr-29-2011
56 Beckman Coulter Inc. II Apr-20-2011
57 Beckman Coulter Inc. II Apr-14-2011
58 Beckman Coulter Inc. II Apr-14-2011
59 Beckman Coulter Inc. II Apr-13-2011
60 Beckman Coulter Inc. II Apr-12-2011
61 Beckman Coulter Inc. II Apr-04-2011
62 Beckman Coulter Inc. II Mar-18-2011
63 Beckman Coulter Inc. III Sep-01-2010
64 Beckman Coulter Inc. II Jun-25-2010
65 Beckman Coulter Inc. II May-26-2010
66 Beckman Coulter Inc. II May-26-2010
67 Beckman Coulter Inc. III May-26-2010
68 Beckman Coulter, Inc. II Nov-22-2019
69 Becton, Dickinson and Company, BD Biosciences II Nov-03-2022
70 Becton, Dickinson and Company, BD Biosciences III Aug-09-2016
71 Becton, Dickinson and Company, BD Biosciences II Jul-21-2016
72 Becton, Dickinson and Company, BD Biosciences II Apr-26-2016
73 Becton, Dickinson and Company, BD Biosciences III Sep-24-2015
74 Clinical Diagnostic Solutions, Inc. II Feb-05-2020
75 JAS Diagnostics Inc. II Jun-30-2017
76 Jas Diagnostics/Drew Scientific II Apr-27-2016
77 Pointcare Technologies, Inc. II Mar-08-2012
78 SIGHT DIAGNOSTICS LTD II Jul-27-2022
79 SIGHT DIAGNOSTICS LTD II Apr-21-2022
80 SIGHT DIAGNOSTICS LTD II Sep-22-2021
81 Siemens Healthcare Diagnostics II Oct-17-2013
82 Siemens Healthcare Diagnostics, Inc. II Apr-09-2021
83 Siemens Healthcare Diagnostics, Inc. II Dec-08-2016
84 Siemens Healthcare Diagnostics, Inc. II Apr-20-2016
85 Siemens Medical Solutions USA, Inc. II Apr-06-2011
86 Sysmex America Inc II Apr-14-2017
87 Sysmex America Inc II Oct-18-2013
88 Sysmex America, Inc. II Nov-06-2012
89 Sysmex Corporation II Jun-10-2016
90 Varian Medical Systems Oncology Systems II Jan-08-2011
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