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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device kit, anaerobic identification
Regulation Description Microorganism differentiation and identification device.
Product CodeJSP
Regulation Number 866.2660
Device Class 1

MDR Year MDR Reports MDR Events
2016 12 15
2017 23 23
2018 10 10
2020 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect Or Inadequate Test Results 34 34
Incorrect, Inadequate or Imprecise Resultor Readings 12 15

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Patient Involvement 26 26
No Known Impact Or Consequence To Patient 14 17
No Consequences Or Impact To Patient 9 11
Patient Problem/Medical Problem 2 2

Recalls
Manufacturer Recall Class Date Posted
1 BioMerieux SA II Jun-12-2018
2 Biomerieux Inc II May-22-2017
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