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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
ABBOTT LABORATORIES
  SUBSTANTIALLY EQUIVALENT 2
AD ASTRA DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ATHELAS INC.
  SUBSTANTIALLY EQUIVALENT 2
BECKMAN COULTER
  SE - WITH LIMITATIONS 1
  SUBSTANTIALLY EQUIVALENT 2
BECKMAN COULTER, INC.
  SUBSTANTIALLY EQUIVALENT 1
NANOENTEK, INC.
  SUBSTANTIALLY EQUIVALENT 2
PIXCELL MEDICAL TECHNOLOGIES, LTD.
  SUBSTANTIALLY EQUIVALENT 2
ROCHE DIAGNOSTICS HEMATOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 1
S.D. SIGHT DIAGNOSTICS LTD.
  SUBSTANTIALLY EQUIVALENT 1
SIGHT DIAGNOSTICS LTD.
  SUBSTANTIALLY EQUIVALENT 1
SYSMEX AMERICA, INC.
  SUBSTANTIALLY EQUIVALENT 4

MDR Year MDR Reports MDR Events
2018 497 497
2019 908 908
2020 342 342
2021 391 391
2022 198 198
2023 123 123

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 1689 1689
Fluid/Blood Leak 201 201
Low Test Results 158 158
High Test Results 79 79
Output Problem 63 63
Leak/Splash 36 36
Adverse Event Without Identified Device or Use Problem 33 33
Use of Device Problem 31 31
Smoking 25 25
Thermal Decomposition of Device 15 15
Device Markings/Labelling Problem 15 15
Low Readings 14 14
Mechanical Problem 11 11
Contamination 10 10
Device Handling Problem 8 8
Patient Data Problem 7 7
Improper or Incorrect Procedure or Method 7 7
Incorrect Or Inadequate Test Results 6 6
Fire 6 6
Sparking 5 5
Unintended Electrical Shock 5 5
Missing Information 4 4
Incorrect Measurement 4 4
Overheating of Device 3 3
Charred 3 3
Computer Software Problem 3 3
High Readings 3 3
Wrong Label 3 3
Improper Device Output 3 3
Insufficient Information 3 3
Unintended Movement 2 2
Device Contamination with Chemical or Other Material 2 2
Electrical Shorting 2 2
Contamination of Device Ingredient or Reagent 2 2
Sharp Edges 2 2
Device Fell 2 2
Data Problem 2 2
Failure to Read Input Signal 2 2
Blocked Connection 1 1
Contamination /Decontamination Problem 1 1
Arcing 1 1
Defective Component 1 1
Obstruction of Flow 1 1
Inadequate or Insufficient Training 1 1
Retraction Problem 1 1
Break 1 1
Complete Blockage 1 1
Display or Visual Feedback Problem 1 1
Electrical /Electronic Property Problem 1 1
False Negative Result 1 1
Device Remains Activated 1 1
Difficult to Remove 1 1
Melted 1 1
Device Maintenance Issue 1 1
Missing Test Results 1 1
Explosion 1 1
Non Reproducible Results 1 1
Intermittent Communication Failure 1 1
Priming Problem 1 1
Fail-Safe Problem 1 1
Installation-Related Problem 1 1
Material Integrity Problem 1 1
Mechanical Jam 1 1
Human-Device Interface Problem 1 1
Packaging Problem 1 1
Temperature Problem 1 1
Appropriate Term/Code Not Available 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 1319 1319
No Clinical Signs, Symptoms or Conditions 734 734
No Known Impact Or Consequence To Patient 195 195
No Patient Involvement 130 130
Test Result 65 65
No Code Available 12 12
Needle Stick/Puncture 6 6
Injury 6 6
Eye Injury 5 5
Exposure to Body Fluids 3 3
Misdiagnosis 3 3
No Information 2 2
Electric Shock 2 2
Head Injury 2 2
Unspecified Blood or Lymphatic problem 2 2
Insufficient Information 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Unspecified Eye / Vision Problem 1 1
Swelling/ Edema 1 1
Cancer 1 1
Pain 1 1
Shock 1 1
Chemical Exposure 1 1
Abdominal Pain 1 1
Fall 1 1
Fever 1 1
Fracture, Arm 1 1
Reaction 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Laboratories II Oct-22-2019
2 Abbott Laboratories II Mar-29-2019
3 Beckman Coulter Inc. I May-23-2019
4 Beckman Coulter Inc. I Nov-20-2018
5 Beckman Coulter, Inc. II Nov-22-2019
6 Becton, Dickinson and Company, BD Biosciences II Nov-03-2022
7 Clinical Diagnostic Solutions, Inc. II Feb-05-2020
8 SIGHT DIAGNOSTICS LTD II Jul-27-2022
9 SIGHT DIAGNOSTICS LTD II Apr-21-2022
10 SIGHT DIAGNOSTICS LTD II Sep-22-2021
11 Siemens Healthcare Diagnostics, Inc. II Apr-09-2021
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