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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device gram positive identification panel
Product CodeLQL
Regulation Number 866.2660
Device Class 1

MDR Year MDR Reports MDR Events
2018 70 70
2019 1 1
2020 3 3
2021 4 4
2022 6 6
2023 7 7

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 53 53
Incorrect Or Inadequate Test Results 36 36
Device Markings/Labelling Problem 1 1
Leak/Splash 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 32 32
No Patient Involvement 27 27
No Clinical Signs, Symptoms or Conditions 17 17
No Consequences Or Impact To Patient 15 15
Misdiagnosis 2 2

Recalls
Manufacturer Recall Class Date Posted
1 BioMerieux SA II Jun-12-2018
2 Biomerieux Inc II Jan-04-2023
3 Biomerieux Inc II Oct-11-2018
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