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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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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 CodePER
Regulation Number 862.2750
Device Class 1

MDR Year MDR Reports MDR Events
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 93 93
Incorrect, Inadequate or Imprecise Result or Readings 19 19
Leak/Splash 10 10
Contamination 5 5
Computer Software Problem 3 3
Mechanical Problem 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Non Reproducible Results 1 1
Overfill 1 1
Excess Flow or Over-Infusion 1 1
Infusion or Flow Problem 1 1
Free or Unrestricted Flow 1 1
Improper or Incorrect Procedure or Method 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 134 134
No Consequences Or Impact To Patient 3 3
No Patient Involvement 2 2
Abrasion 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Beckman Coulter, Inc. II Feb-02-2026
2 Beckman Coulter, Inc. II Oct-30-2025
3 Becton, Dickinson and Company, BD Bio Sciences II Oct-03-2024
4 Sysmex America, Inc. II Feb-05-2025
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