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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
Regulation Description Microorganism differentiation and identification device.
Product CodeJXB
Regulation Number 866.2660
Device Class 1

MDR Year MDR Reports MDR Events
2020 12 12
2021 37 37
2022 10 10
2023 10 10
2024 2 2
2025 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 65 65
Nonstandard Device 6 6
False Negative Result 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 59 59
No Known Impact Or Consequence To Patient 12 12
No Patient Involvement 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Biomerieux Inc II Jan-04-2023
2 Biomerieux Inc II Jan-25-2022
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