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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device device, general purpose, microbiology, diagnostic
Product CodeLIB
Regulation Number 866.2660
Device Class 1

MDR Year MDR Reports MDR Events
2016 3 3
2017 1 1
2023 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
False Negative Result 2 2
Fluid/Blood Leak 1 1
Device Markings/Labelling Problem 1 1
Device Operates Differently Than Expected 1 1
Infusion or Flow Problem 1 1
Device Contaminated During Manufacture or Shipping 1 1
Contamination 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Patient Involvement 3 3
No Clinical Signs, Symptoms or Conditions 2 2
No Known Impact Or Consequence To Patient 1 1

Recalls
Manufacturer Recall Class Date Posted
1 BioMerieux SA II Feb-04-2016
2 BioMerieux SA II Apr-18-2014
3 Biomerieux Inc II Mar-12-2014
4 Remel Inc II Dec-16-2014
5 Remel Inc II Apr-18-2014
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