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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device fibrin split products
Regulation Description Fibrinogen/fibrin degradation products assay.
Product CodeGHH
Regulation Number 864.7320
Device Class 2

MDR Year MDR Reports MDR Events
2015 14 14
2016 8 8
2017 18 18
2018 19 19
2019 19 19
2020 17 17

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 33 33
Low Test Results 32 32
Incorrect, Inadequate or Imprecise Resultor Readings 12 12
Non Reproducible Results 7 7
Test Strip 6 6
Incorrect Or Inadequate Test Results 6 6
High Readings 3 3
False Negative Result 1 1
Incorrect Measurement 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 75 75
No Known Impact Or Consequence To Patient 14 14
No Code Available 5 5
Thrombus 2 2
Thrombosis 1 1
Pain 1 1
Thromboembolism 1 1

Recalls
Manufacturer Recall Class Date Posted
1 BBI SOLUTIONS OEM LTD II Oct-27-2016
2 Lsi Medience Corporation II Nov-21-2016
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