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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
2015 18 18
2016 35 62
2017 89 89
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 Or Inadequate Test Results 122 122
Incorrect, Inadequate or Imprecise Result or Readings 108 135
Use of Device Problem 1 1
Improper or Incorrect Procedure or Method 1 1
Fluid/Blood Leak 1 1
Leak/Splash 1 1
Device Markings/Labelling Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 80 93
No Patient Involvement 75 88
No Consequences Or Impact To Patient 70 97
No Clinical Signs, Symptoms or Conditions 17 17
Misdiagnosis 5 5
Test Result 1 1
Bacterial Infection 1 1
Exposure to Body Fluids 1 1
Eye Injury 1 1
Intraocular Infection 1 1

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
4 Biomerieux Inc II Sep-18-2017
5 Biomerieux Inc II May-22-2017
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