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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
2021 23 23
2022 11 11
2023 6 6
2024 4 4
2025 4 4
2026 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Low Test Results 18 18
High Test Results 17 17
Incorrect, Inadequate or Imprecise Result or Readings 11 11
Non Reproducible Results 4 4
High Readings 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 37 37
Insufficient Information 2 2
Stenosis 2 2
Myocardial Infarction 2 2
Syncope/Fainting 1 1
Hip Fracture 1 1
Myalgia 1 1
Angina 1 1
Limb Pain 1 1
Swelling/ Edema 1 1
Cardiac Enzyme Elevation 1 1
No Consequences Or Impact To Patient 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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