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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

Device Problems MDRs with this Device Problem Events in those MDRs
Structural Problem 30 30
Incorrect, Inadequate or Imprecise Result or Readings 10 10
False Negative Result 7 7
False Positive Result 3 3
Mechanical Problem 2 2
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 56 56
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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