Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
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 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Use of Device Problem 14 14
Incorrect, Inadequate or Imprecise Result or Readings 13 13
Insufficient Information 9 9
Adverse Event Without Identified Device or Use Problem 8 8
Low Test Results 8 8
Incorrect Measurement 5 5
Improper or Incorrect Procedure or Method 5 5
Appropriate Term/Code Not Available 5 5
Leak/Splash 3 3
Output Problem 3 3
Thermal Decomposition of Device 3 3
False Negative Result 3 3
Smoking 2 2
Use of Incorrect Control/Treatment Settings 2 2
Material Twisted/Bent 2 2
High Test Results 2 2
Temperature Problem 1 1
Misassembly by Users 1 1
Misassembly During Maintenance/Repair 1 1
Break 1 1
Computer Software Problem 1 1
Melted 1 1
Misconnection 1 1
Device Emits Odor 1 1
Overheating of Device 1 1
False Positive Result 1 1
High Readings 1 1
Failure to Obtain Sample 1 1
Electrical Shorting 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 24 24
No Known Impact Or Consequence To Patient 23 23
No Consequences Or Impact To Patient 7 7
Insufficient Information 4 4
Exposure to Body Fluids 3 3
Death 3 3
Pulmonary Embolism 2 2
Patient Problem/Medical Problem 2 2
Aortic Dissection 2 2
Chemical Exposure 2 2
No Patient Involvement 2 2
No Code Available 2 2
Thrombosis/Thrombus 1 1
Thromboembolism 1 1
Needle Stick/Puncture 1 1
Embolus 1 1
Hemorrhage/Bleeding 1 1
Miscarriage 1 1
Myocardial Infarction 1 1
Thrombosis 1 1
Ventricular Fibrillation 1 1
Misdiagnosis 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
-
-