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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 1
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
S.D. SIGHT DIAGNOSTICS LTD.
  SUBSTANTIALLY EQUIVALENT 1
SIGHT DIAGNOSTICS LTD.
  SUBSTANTIALLY EQUIVALENT 1
SYSMEX AMERICA, INC.
  SUBSTANTIALLY EQUIVALENT 5

MDR Year MDR Reports MDR Events
2019 908 908
2020 342 342
2021 391 391
2022 198 198
2023 143 143
2024 12 12

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 1348 1348
Fluid/Blood Leak 200 200
Low Test Results 140 140
High Test Results 59 59
Leak/Splash 38 38
Use of Device Problem 30 30
Adverse Event Without Identified Device or Use Problem 26 26
Smoking 21 21
Device Markings/Labelling Problem 16 16
Low Readings 14 14
Output Problem 13 13
Thermal Decomposition of Device 12 12
Improper or Incorrect Procedure or Method 10 10
Contamination 10 10
Patient Data Problem 6 6
Unintended Electrical Shock 5 5
Sparking 5 5
Fire 4 4
Missing Information 4 4
Incorrect Measurement 4 4
Mechanical Problem 4 4
Insufficient Information 3 3
Wrong Label 3 3
Contamination of Device Ingredient or Reagent 3 3
High Readings 3 3
Obstruction of Flow 2 2
Device Fell 2 2
Failure to Read Input Signal 2 2
Device Contamination with Chemical or Other Material 2 2
Unintended Movement 2 2
Electrical Shorting 2 2
Device Handling Problem 2 2
Overheating of Device 2 2
Computer Software Problem 2 2
Sharp Edges 1 1
Break 1 1
Temperature Problem 1 1
Display or Visual Feedback Problem 1 1
Blocked Connection 1 1
Installation-Related Problem 1 1
False Negative Result 1 1
Mechanical Jam 1 1
Arcing 1 1
Material Integrity Problem 1 1
Data Problem 1 1
Defective Component 1 1
Missing Test Results 1 1
Difficult to Remove 1 1
Retraction Problem 1 1
Appropriate Term/Code Not Available 1 1
Device Remains Activated 1 1
Contamination /Decontamination Problem 1 1
Priming Problem 1 1
Fail-Safe Problem 1 1
Non Reproducible Results 1 1
Electrical /Electronic Property Problem 1 1
Intermittent Communication Failure 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 962 962
No Clinical Signs, Symptoms or Conditions 765 765
No Known Impact Or Consequence To Patient 125 125
No Patient Involvement 123 123
Test Result 10 10
Needle Stick/Puncture 6 6
Injury 5 5
No Code Available 5 5
Eye Injury 4 4
Exposure to Body Fluids 3 3
Misdiagnosis 3 3
Unspecified Blood or Lymphatic problem 2 2
Insufficient Information 2 2
Electric Shock 2 2
No Information 2 2
Swelling/ Edema 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Fall 1 1
Fever 1 1
Fracture, Arm 1 1
Cancer 1 1
Pain 1 1
Head Injury 1 1
Chemical Exposure 1 1
Shock 1 1
Abdominal Pain 1 1
Reaction 1 1
Unspecified Eye / Vision Problem 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Laboratories II Dec-21-2023
2 Abbott Laboratories II Oct-22-2019
3 Abbott Laboratories II Mar-29-2019
4 Beckman Coulter Inc. I May-23-2019
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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