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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
Regulation Description Multipurpose system for in vitro coagulation studies.
Product CodeJPA
Regulation Number 864.5425
Device Class 2


Premarket Reviews
ManufacturerDecision
ACCRIVA DIAGNOSTICS, INC.
  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
2020 18 18
2021 7 7
2022 9 9
2023 11 11
2024 8 8

Device Problems MDRs with this Device Problem Events in those MDRs
Low Test Results 9 9
Incorrect, Inadequate or Imprecise Result or Readings 7 7
Use of Device Problem 7 7
Insufficient Information 5 5
Incorrect Measurement 4 4
Leak/Splash 3 3
False Negative Result 3 3
Appropriate Term/Code Not Available 3 3
Output Problem 2 2
Thermal Decomposition of Device 2 2
Adverse Event Without Identified Device or Use Problem 2 2
High Test Results 2 2
Improper or Incorrect Procedure or Method 2 2
Break 1 1
Smoking 1 1
Failure to Obtain Sample 1 1
High Readings 1 1
Use of Incorrect Control/Treatment Settings 1 1
Electrical Shorting 1 1
Computer Software Problem 1 1
Temperature Problem 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 10 10
Insufficient Information 5 5
Exposure to Body Fluids 3 3
No Consequences Or Impact To Patient 3 3
Chemical Exposure 2 2
Hemorrhage/Bleeding 2 2
Ventricular Fibrillation 1 1
Needle Stick/Puncture 1 1
Thrombosis/Thrombus 1 1
No Patient Involvement 1 1
Swelling/ Edema 1 1
Myocardial Infarction 1 1
Pulmonary Embolism 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 Siemens Healthcare Diagnostics, Inc. II Apr-19-2021
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