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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
Product CodeGHH
Regulation Number 864.7320
Device Class 2

MDR Year MDR Reports MDR Events
2019 19 19
2020 16 16
2021 23 23
2022 11 11
2023 6 6
2024 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Low Test Results 31 31
High Test Results 22 22
Incorrect, Inadequate or Imprecise Result or Readings 17 17
Non Reproducible Results 6 6
High Readings 4 4
Adverse Event Without Identified Device or Use Problem 1 1
Incorrect Measurement 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 36 36
No Clinical Signs, Symptoms or Conditions 33 33
No Code Available 2 2
Insufficient Information 2 2
Stenosis 2 2
Myocardial Infarction 2 2
Myalgia 1 1
Angina 1 1
Swelling/ Edema 1 1
Cardiac Enzyme Elevation 1 1
Pulmonary Embolism 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Roche Diagnostics Operations, Inc. II Nov-20-2023
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