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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device nephelometer, for clinical use
Product CodeJQX
Regulation Number 862.2700
Device Class 1

MDR Year MDR Reports MDR Events
2014 1 1
2018 1 1
2019 1 1
2020 10 10
2021 12 12
2022 24 24
2023 27 27
2024 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Contamination 26 26
Incorrect, Inadequate or Imprecise Result or Readings 23 23
Low Test Results 17 17
Microbial Contamination of Device 5 5
High Test Results 3 3
Mechanical Problem 2 2
Crack 1 1
Leak/Splash 1 1
Contamination /Decontamination Problem 1 1
Device Markings/Labelling Problem 1 1
Output Problem 1 1
Patient Data Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 71 71
No Known Impact Or Consequence To Patient 8 8

Recalls
Manufacturer Recall Class Date Posted
1 Beckman Coulter Inc. II Aug-10-2010
2 Becton Dickinson & Co. III Dec-06-2017
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