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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
2017 77 77
2018 88 88
2019 12 12
2021 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect Or Inadequate Test Results 122 122
Incorrect, Inadequate or Imprecise Resultor Readings 51 51
Difficult to Open or Remove Packaging Material 6 6
Device Emits Odor 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 73 73
No Patient Involvement 48 48
No Consequences Or Impact To Patient 45 45
Injury 6 6
Misdiagnosis 4 4
No Clinical Signs, Symptoms or Conditions 3 3
Pain 2 2
Vomiting 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Biomerieux Inc II May-22-2017
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