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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


Premarket Reviews
ManufacturerDecision
DIAZYME LABORATORIES
  SUBSTANTIALLY EQUIVALENT 1
MITSUBISHI KAGAKU IATRON
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 4 4
2015 14 14
2016 8 8
2017 18 18
2018 19 19
2019 19 19
2020 16 16
2021 23 23
2022 11 11
2023 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 50 50
Low Test Results 47 47
Incorrect, Inadequate or Imprecise Result or Readings 18 18
Non Reproducible Results 10 10
Incorrect Or Inadequate Test Results 6 6
High Readings 4 4
Device Displays Incorrect Message 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Incorrect Measurement 1 1
False Negative Result 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 76 76
No Clinical Signs, Symptoms or Conditions 32 32
No Known Impact Or Consequence To Patient 17 17
No Code Available 5 5
Stenosis 2 2
Myocardial Infarction 2 2
Thrombus 2 2
Pain 1 1
Thrombosis 1 1
Pulmonary Embolism 1 1
Angina 1 1
Cardiac Enzyme Elevation 1 1
Thromboembolism 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Alere San Diego, Inc. II Jun-06-2014
2 Alere San Diego, Inc. I Jul-06-2012
3 BBI SOLUTIONS OEM LTD II Oct-27-2016
4 Lsi Medience Corporation II Nov-21-2016
5 Roche Diagnostics Operations, Inc. II Nov-20-2023
6 Tcoag Us, Incorporated II Oct-07-2011
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