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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device kit, fastidious organisms
Product CodeJST
Regulation Number 866.2660
Device Class 1

MDR Year MDR Reports MDR Events
2017 14 14
2018 9 9
2021 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect Or Inadequate Test Results 16 16
Incorrect, Inadequate or Imprecise Result or Readings 8 8

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Patient Involvement 10 10
No Known Impact Or Consequence To Patient 10 10
No Consequences Or Impact To Patient 3 3
Misdiagnosis 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 Aug-17-2018
4 Biomerieux Inc II May-22-2017
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