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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device device, microtiter diluting/dispensing
Regulation Description Microtiter diluting and dispensing device.
Product CodeJTC
Regulation Number 866.2500
Device Class 1

MDR Year MDR Reports MDR Events
2020 2 2
2021 8 8
2022 26 26
2023 15 15
2024 10 10
2025 7 7

Device Problems MDRs with this Device Problem Events in those MDRs
Structural Problem 30 30
Incorrect, Inadequate or Imprecise Result or Readings 16 16
False Negative Result 7 7
Mechanical Problem 3 3
False Positive Result 3 3
Break 1 1
Fire 1 1
Collapse 1 1
Device Fell 1 1
Patient Data Problem 1 1
Contamination 1 1
Unintended System Motion 1 1
Application Network Problem 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 63 63
No Consequences Or Impact To Patient 2 2
Burn(s) 1 1
Burning Sensation 1 1
Exposure to Body Fluids 1 1
Insufficient Information 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Becton Dickinson & Co. II Apr-20-2023
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