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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device gram negative identification panel
Regulation Description Microorganism differentiation and identification device.
Product CodeLQM
Regulation Number 866.2660
Device Class 1

MDR Year MDR Reports MDR Events
2021 3 3
2022 7 7
2023 30 32
2024 34 36
2025 17 17

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 89 91
False Positive Result 2 4

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 91 95

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