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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device discs, strips and reagents, microorganism differentiation
Regulation Description Microorganism differentiation and identification device.
Product CodeJTO
Regulation Number 866.2660
Device Class 1

MDR Year MDR Reports MDR Events
2016 44 67
2017 42 42
2018 3 3
2019 4 4
2020 7 7
2021 8 8

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Resultor Readings 59 82
Incorrect Or Inadequate Test Results 43 43
False Positive Result 3 3
Fluid Leak 1 1
Tear, Rip or Hole in Device Packaging 1 1
Device Operates Differently Than Expected 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 46 62
No Patient Involvement 32 37
No Consequences Or Impact To Patient 28 51
No Clinical Signs, Symptoms or Conditions 7 7
Meningitis 1 1
Laceration(s) 1 1
Skin Discoloration 1 1

Recalls
Manufacturer Recall Class Date Posted
1 BioMerieux SA II Jun-12-2018
2 Gibson Bioscience II Sep-10-2021
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