TPLC - Total Product Life Cycle

• Device: automated pipetting, diluting and specimen processing workstations for flow cytometric analysis
• Regulation Description: Pipetting and diluting system for clinical use.
• Definition: Flow cytometer specimen processors are automated or semi-automated workstations designed to be used alone or in combination with manual methods to pipette, dilute and process human specimens in preparation for flow cytometric analysis.
• Product Code: PER
• Regulation Number: 862.2750
• Device Class: 1

MDR Year	MDR Reports	MDR Events
2016	2	2
2020	37	37
2021	54	54
2022	63	63
2023	11	11
2024	3	3
2025	6	6
2026	1	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Fluid/Blood Leak	116	116
Incorrect, Inadequate or Imprecise Result or Readings	22	22
Leak/Splash	7	7
Contamination	5	5
Computer Software Problem	3	3
Adverse Event Without Identified Device or Use Problem	2	2
Device Contamination with Chemical or Other Material	2	2
Failure to Sense	2	2
Mechanical Problem	2	2
Failure to Deliver	1	1
Output Problem	1	1
Improper or Incorrect Procedure or Method	1	1
Non Reproducible Results	1	1
Device Operates Differently Than Expected	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	143	143
No Consequences Or Impact To Patient	21	21
No Patient Involvement	20	20
No Known Impact Or Consequence To Patient	2	2
Abrasion	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Beckman Coulter Inc.	II	Jul-07-2017
2	Beckman Coulter, Inc.	II	Feb-02-2026
3	Beckman Coulter, Inc.	II	Oct-30-2025
4	Becton, Dickinson and Company, BD Bio Sciences	II	Oct-03-2024
5	Becton, Dickinson and Company, BD Biosciences	II	Jun-11-2020
6	Sysmex America, Inc.	II	Feb-05-2025
7	Sysmex America, Inc.	II	Jul-22-2020