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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device flow cytometric reagents and accessories.
Definition To identify and classify cells or other particles in suspension by their inherent physical properties or associated fluorescent molecules in order to provide information about the distribution or number cells in suspension or their level of protein expression. These characteristics may aid in the diagnosis of conditions such as immunodeficiency and cancer.
Product CodeOYE
Regulation Number 864.5220
Device Class 2


Premarket Reviews
ManufacturerDecision
BECKMAN COULTER, INC
  SUBSTANTIALLY EQUIVALENT 1
BECKMAN COULTER, INC.
  SUBSTANTIALLY EQUIVALENT 1
BECTON, DICKINSON & COMPANY
  SUBSTANTIALLY EQUIVALENT 2
BECTON, DICKINSON AND COMPANY
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 6 6
2020 173 173
2021 251 251
2022 193 193
2023 142 142
2024 29 29

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 353 353
Incorrect, Inadequate or Imprecise Result or Readings 275 275
Contamination 100 100
Leak/Splash 28 28
Improper or Incorrect Procedure or Method 10 10
Device Markings/Labelling Problem 6 6
Break 4 4
Data Problem 4 4
Device Contamination with Chemical or Other Material 4 4
Use of Device Problem 3 3
Adverse Event Without Identified Device or Use Problem 3 3
Contamination of Device Ingredient or Reagent 3 3
Signal Artifact/Noise 2 2
Non Reproducible Results 2 2
Patient Data Problem 2 2
Unable to Obtain Readings 2 2
Computer Software Problem 2 2
Device Ingredient or Reagent Problem 1 1
Pressure Problem 1 1
Device Contamination with Body Fluid 1 1
Electrical Power Problem 1 1
Defective Component 1 1
Application Program Problem: Dose Calculation Error 1 1
Protective Measures Problem 1 1
Flushing Problem 1 1
Inadequate or Insufficient Training 1 1
Electrical /Electronic Property Problem 1 1
False Positive Result 1 1
Loose or Intermittent Connection 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 645 645
No Consequences Or Impact To Patient 106 106
No Patient Involvement 85 85
No Known Impact Or Consequence To Patient 10 10
Test Result 3 3
Electric Shock 2 2
Chemical Exposure 2 2
Superficial (First Degree) Burn 1 1
Tingling 1 1
No Information 1 1
Injury 1 1
Numbness 1 1
Eye Injury 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Becton, Dickinson and Company, BD Biosciences II Jul-12-2024
2 Becton, Dickinson and Company, BD Biosciences II Oct-09-2019
3 Becton, Dickinson and Company, BD Biosciences III Feb-01-2019
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