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	4
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	357	357
Incorrect, Inadequate or Imprecise Result or Readings	266	266
Contamination	100	100
Leak/Splash	31	31
Device Operational Issue	30	30
Improper or Incorrect Procedure or Method	10	10
Device Operates Differently Than Expected	6	6
Device Markings/Labelling Problem	6	6
Break	5	5
Device Contamination with Chemical or Other Material	4	4
Data Problem	4	4
Adverse Event Without Identified Device or Use Problem	3	3
Use of Device Problem	3	3
Output Problem	3	3
Computer Software Problem	2	2
Unable to Obtain Readings	2	2
Contamination of Device Ingredient or Reagent	2	2
Pressure Problem	2	2
Patient Data Problem	2	2
Signal Artifact/Noise	2	2
Non Reproducible Results	2	2
Device Inoperable	2	2
Device Ingredient or Reagent Problem	1	1
Defective Component	1	1
Device Contamination with Body Fluid	1	1
False Positive Result	1	1
Fire	1	1
Electrical /Electronic Property Problem	1	1
Device Displays Incorrect Message	1	1
Application Program Problem: Dose Calculation Error	1	1
Electrical Power Problem	1	1
Protective Measures Problem	1	1
Inadequate or Insufficient Training	1	1
Device Emits Odor	1	1
Loose or Intermittent Connection	1	1
Thermal Decomposition of Device	1	1
Mechanical Problem	1	1
Flushing Problem	1	1
Charred	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	633	633
No Consequences Or Impact To Patient	114	114
No Patient Involvement	85	85
Test Result	33	33
No Known Impact Or Consequence To Patient	17	17
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	BD Biosciences, Systems & Reagents	II	Jul-02-2014
3	Beckman Coulter Inc.	II	Oct-11-2018
4	Beckman Coulter Inc.	II	Apr-10-2018
5	Beckman Coulter Inc.	II	Sep-19-2017
6	Beckman Coulter Inc.	II	Apr-17-2017
7	Beckman Coulter Inc.	II	Nov-21-2016
8	Beckman Coulter Inc.	II	Sep-28-2016
9	Becton, Dickinson and Company, BD Biosciences	II	Oct-09-2019
10	Becton, Dickinson and Company, BD Biosciences	III	Feb-01-2019
11	Becton, Dickinson and Company, BD Biosciences	III	Jul-13-2018