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 Code	OYE
Regulation Number	864.5220
Device Class	2

Premarket Reviews
Manufacturer	Decision
BD BIOSCIENCES
	SUBSTANTIALLY EQUIVALENT	2
BECKMAN COULTER
	SUBSTANTIALLY EQUIVALENT	1
BECKMAN COULTER, INC
	SUBSTANTIALLY EQUIVALENT	1
BECKMAN COULTER, INC.
	SUBSTANTIALLY EQUIVALENT	2
BECTON, DICKINSON & COMPANY
	SUBSTANTIALLY EQUIVALENT	2
BECTON, DICKINSON AND COMPANY
	SUBSTANTIALLY EQUIVALENT	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Fluid/Blood Leak	355	355
Incorrect, Inadequate or Imprecise Result or Readings	269	269
Contamination	100	100
Leak/Splash	30	30
Device Operational Issue	30	30
Improper or Incorrect Procedure or Method	10	10
Device Markings/Labelling Problem	6	6
Data Problem	4	4
Device Contamination with Chemical or Other Material	4	4
Break	4	4
Adverse Event Without Identified Device or Use Problem	3	3
Output Problem	3	3
Use of Device Problem	3	3
Unable to Obtain Readings	2	2
Contamination of Device Ingredient or Reagent	2	2
Pressure Problem	2	2
Patient Data Problem	2	2
Non Reproducible Results	2	2
Signal Artifact/Noise	2	2
Computer Software Problem	2	2
Thermal Decomposition of Device	1	1
Charred	1	1
Application Program Problem: Dose Calculation Error	1	1
Electrical /Electronic Property Problem	1	1
False Positive Result	1	1
Fire	1	1
Loose or Intermittent Connection	1	1
Mechanical Problem	1	1
Device Emits Odor	1	1
Inadequate or Insufficient Training	1	1
Device Inoperable	1	1
Flushing Problem	1	1
Electrical Power Problem	1	1
Protective Measures Problem	1	1
Device Ingredient or Reagent Problem	1	1
Device Operates Differently Than Expected	1	1
Defective Component	1	1
Device Contamination with Body Fluid	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	636	636
No Consequences Or Impact To Patient	111	111
No Patient Involvement	85	85
Test Result	33	33
No Known Impact Or Consequence To Patient	11	11
Not Applicable	6	6
Electric Shock	2	2
Chemical Exposure	2	2
Superficial (First Degree) Burn	1	1
Injury	1	1
Numbness	1	1
Eye Injury	1	1
Tingling	1	1
No Information	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	BD Biosciences, Systems & Reagents	II	Jun-26-2015
2	Beckman Coulter Inc.	II	Oct-11-2018
3	Beckman Coulter Inc.	II	Apr-10-2018
4	Beckman Coulter Inc.	II	Sep-19-2017
5	Beckman Coulter Inc.	II	Apr-17-2017
6	Beckman Coulter Inc.	II	Nov-21-2016
7	Beckman Coulter Inc.	II	Sep-28-2016
8	Becton, Dickinson and Company, BD Biosciences	II	Oct-09-2019
9	Becton, Dickinson and Company, BD Biosciences	III	Feb-01-2019
10	Becton, Dickinson and Company, BD Biosciences	III	Jul-13-2018