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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
2021 37 37
2022 10 10
2023 10 10
2024 2 2
2025 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 58 58
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 64 64
No Known Impact Or Consequence To Patient 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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