TPLC - Total Product Life Cycle

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Device	flow cytometric reagents and accessories.
Regulation Description	Automated differential cell counter.
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

Device Problems	MDRs with this Device Problem	Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings	245	245
Fluid/Blood Leak	236	236
Contamination	120	120
Leak/Splash	26	26
Improper or Incorrect Procedure or Method	10	10
Device Markings/Labelling Problem	5	5
Contamination of Device Ingredient or Reagent	5	5
Break	4	4
Use of Device Problem	4	4
Mechanical Problem	3	3
Signal Artifact/Noise	2	2
Non Reproducible Results	2	2
Unable to Obtain Readings	2	2
Data Problem	2	2
Device Contamination with Chemical or Other Material	2	2
Device Ingredient or Reagent Problem	1	1
Pressure Problem	1	1
Device Contamination with Body Fluid	1	1
Output Problem	1	1
Electrical Power Problem	1	1
Defective Component	1	1
Application Program Problem: Dose Calculation Error	1	1
Calibration Problem	1	1
Computer Software Problem	1	1
Flushing Problem	1	1
False Positive Result	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	642	642
No Consequences Or Impact To Patient	24	24
No Patient Involvement	11	11

Recalls
Manufacturer		Recall Class	Date Posted
1	Beckman Coulter Inc.	II	Nov-18-2025
2	Becton, Dickinson and Company, BD Bio Sciences	II	Dec-23-2024
3	Becton, Dickinson and Company, BD Biosciences	II	Jul-12-2024