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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device system, multipurpose for in vitro coagulation studies
Product CodeJPA
Regulation Number 864.5425
Device Class 2


Premarket Reviews
ManufacturerDecision
ACCRIVA DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 2
DIAGNOSTIC GRIFOLS, S.A.
  SUBSTANTIALLY EQUIVALENT 1
DIAGNOSTICA STAGO SAS
  SUBSTANTIALLY EQUIVALENT 1
HAEMONETICS CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
INSTRUMENTATION LABORATORY
  SUBSTANTIALLY EQUIVALENT 1
INSTRUMENTATION LABORATORY CO.
  SUBSTANTIALLY EQUIVALENT 1
TEM INNOVATIONS GMBH
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 27 27
2020 18 18
2021 7 7
2022 9 9
2023 11 11
2024 7 7

Device Problems MDRs with this Device Problem Events in those MDRs
Use of Device Problem 15 15
Incorrect, Inadequate or Imprecise Result or Readings 13 13
Insufficient Information 9 9
Low Test Results 9 9
Adverse Event Without Identified Device or Use Problem 8 8
Incorrect Measurement 5 5
Appropriate Term/Code Not Available 5 5
Improper or Incorrect Procedure or Method 5 5
Leak/Splash 3 3
Output Problem 3 3
False Negative Result 3 3
Thermal Decomposition of Device 3 3
Smoking 2 2
Material Twisted/Bent 2 2
High Test Results 2 2
Use of Incorrect Control/Treatment Settings 2 2
Failure to Obtain Sample 1 1
Electrical Shorting 1 1
Device Emits Odor 1 1
Computer Software Problem 1 1
Melted 1 1
Overheating of Device 1 1
False Positive Result 1 1
Temperature Problem 1 1
High Readings 1 1
Misassembly by Users 1 1
Misconnection 1 1
Break 1 1
Misassembly During Maintenance/Repair 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 26 26
No Known Impact Or Consequence To Patient 23 23
No Consequences Or Impact To Patient 7 7
Insufficient Information 5 5
Death 3 3
Exposure to Body Fluids 3 3
Patient Problem/Medical Problem 2 2
No Code Available 2 2
Chemical Exposure 2 2
Aortic Dissection 2 2
No Patient Involvement 2 2
Hemorrhage/Bleeding 2 2
Pulmonary Embolism 2 2
Miscarriage 1 1
Misdiagnosis 1 1
Ventricular Fibrillation 1 1
Needle Stick/Puncture 1 1
Thrombosis/Thrombus 1 1
Thrombosis 1 1
Swelling/ Edema 1 1
Myocardial Infarction 1 1
Thromboembolism 1 1
Embolus 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Diagnostica Stago, Inc. II May-10-2023
2 Haemonetics Corporation II Jun-30-2022
3 Haemonetics Corporation II Jun-28-2022
4 Haemonetics Corporation II Mar-31-2020
5 Helena Laboratories, Corp. II Dec-17-2020
6 Instrumentation Laboratory Co. II Sep-06-2019
7 Siemens Healthcare Diagnostics, Inc. II Apr-19-2021
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