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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
Device antisera, all groups, streptococcus spp.
Product CodeGTZ
Regulation Number 866.3740
Device Class 1

MDR Year MDR Reports MDR Events
2017 2 2
2018 8 8
2019 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
False Negative Result 5 5
Incorrect, Inadequate or Imprecise Resultor Readings 3 3
False Positive Result 2 2
Adverse Event Without Identified Device or Use Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 8 8
No Information 7 7
Device Embedded In Tissue or Plaque 1 1
Misdiagnosis 1 1
Distress 1 1
Meningitis 1 1

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