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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 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 1
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 14 14

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 1644 1644
Fluid/Blood Leak 200 200
Low Test Results 139 139
High Test Results 72 72
Output Problem 62 62
Leak/Splash 32 32
Adverse Event Without Identified Device or Use Problem 30 30
Use of Device Problem 29 29
Smoking 23 23
Thermal Decomposition of Device 13 13
Low Readings 12 12
Device Markings/Labelling Problem 11 11
Contamination 10 10
Device Handling Problem 8 8
Mechanical Problem 8 8
Patient Data Problem 7 7
Incorrect Or Inadequate Test Results 6 6
Unintended Electrical Shock 5 5
Fire 5 5
Incorrect Measurement 4 4
Charred 3 3
Insufficient Information 3 3
Computer Software Problem 3 3
High Readings 3 3
Sparking 3 3
Improper or Incorrect Procedure or Method 3 3
Improper Device Output 3 3
Missing Information 3 3
Data Problem 2 2
Device Fell 2 2
Electrical Shorting 2 2
Device Contamination with Chemical or Other Material 2 2
Failure to Read Input Signal 2 2
Sharp Edges 2 2
Overheating of Device 2 2
Break 1 1
Melted 1 1
Display or Visual Feedback Problem 1 1
Blocked Connection 1 1
Packaging Problem 1 1
Temperature Problem 1 1
Obstruction of Flow 1 1
Retraction Problem 1 1
Appropriate Term/Code Not Available 1 1
Non Reproducible Results 1 1
Intermittent Communication Failure 1 1
Priming Problem 1 1
Contamination /Decontamination Problem 1 1
Explosion 1 1
Electrical /Electronic Property Problem 1 1
Device Remains Activated 1 1
Device Maintenance Issue 1 1
Arcing 1 1
Contamination of Device Ingredient or Reagent 1 1
Defective Component 1 1
Unintended Movement 1 1
Human-Device Interface Problem 1 1
Installation-Related Problem 1 1
Mechanical Jam 1 1
Difficult to Remove 1 1
Inadequate or Insufficient Training 1 1
Complete Blockage 1 1
False Negative Result 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 630 630
No Known Impact Or Consequence To Patient 195 195
No Patient Involvement 130 130
Test Result 65 65
No Code Available 12 12
Injury 6 6
Eye Injury 5 5
Needle Stick/Puncture 5 5
Exposure to Body Fluids 3 3
Misdiagnosis 3 3
Electric Shock 2 2
No Information 2 2
Head Injury 2 2
Insufficient Information 2 2
Cancer 1 1
Unspecified Eye / Vision Problem 1 1
Fracture, Arm 1 1
Reaction 1 1
Unspecified Blood or Lymphatic problem 1 1
Shock 1 1
Chemical Exposure 1 1
Swelling/ Edema 1 1
Fall 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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