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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device kit, identification, yeast
Product CodeJXB
Regulation Number 866.2660
Device Class 1

MDR Year MDR Reports MDR Events
2015 11 11
2016 16 16
2017 18 18
2018 27 27
2019 19 19
2020 12 12
2021 37 37
2022 10 10
2023 10 10
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 123 123
Incorrect Or Inadequate Test Results 31 31
Nonstandard Device 6 6
False Negative Result 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 58 58
No Known Impact Or Consequence To Patient 38 38
No Consequences Or Impact To Patient 38 39
No Patient Involvement 30 30
Fungal Infection 1 1
Death 1 1
Misdiagnosis 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Biomerieux Inc II Jan-04-2023
2 Biomerieux Inc II Jan-25-2022
3 Biomerieux Inc II May-22-2017
4 Remel Inc II Dec-17-2013
5 Remel, Inc III Feb-26-2010
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