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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
Product CodeLQM
Regulation Number 866.2660
Device Class 1

MDR Year MDR Reports MDR Events
2019 12 12
2021 3 3
2022 7 7
2023 30 30
2024 31 31

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 75 75
Difficult to Open or Remove Packaging Material 6 6
False Positive Result 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 71 71
Injury 6 6
No Patient Involvement 4 4
Pain 2 2
No Known Impact Or Consequence To Patient 1 1
No Consequences Or Impact To Patient 1 1

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