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 1
INSTRUMENTATION LABORATORY CO.
  SUBSTANTIALLY EQUIVALENT 1
SEKISUI MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
TEM INNOVATIONS GMBH
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 39 39
2019 27 27
2020 18 18
2021 7 7
2022 9 9
2023 8 8

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 18 18
Use of Device Problem 14 14
Low Test Results 14 14
High Test Results 11 11
Insufficient Information 11 11
Adverse Event Without Identified Device or Use Problem 8 8
Incorrect Or Inadequate Test Results 6 6
Improper or Incorrect Procedure or Method 5 5
Appropriate Term/Code Not Available 5 5
Incorrect Measurement 5 5
Thermal Decomposition of Device 5 5
Output Problem 4 4
False Negative Result 3 3
Use of Incorrect Control/Treatment Settings 2 2
Smoking 2 2
Overheating of Device 2 2
Data Problem 2 2
Electrical Shorting 2 2
Material Twisted/Bent 2 2
Mechanics Altered 1 1
Installation-Related Problem 1 1
High Readings 1 1
Device Displays Incorrect Message 1 1
Non Reproducible Results 1 1
Misassembly During Maintenance/Repair 1 1
Temperature Problem 1 1
Unintended Movement 1 1
Misassembly by Users 1 1
Break 1 1
Melted 1 1
Misconnection 1 1
Device Emits Odor 1 1
Erratic or Intermittent Display 1 1
Charred 1 1
Computer Software Problem 1 1
False Positive Result 1 1
Fire 1 1
Leak/Splash 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 55 55
No Clinical Signs, Symptoms or Conditions 23 23
No Consequences Or Impact To Patient 11 11
No Patient Involvement 3 3
Death 3 3
Patient Problem/Medical Problem 3 3
Missing Value Reason 3 3
Pulmonary Embolism 2 2
No Code Available 2 2
Aortic Dissection 2 2
Blood Loss 1 1
Injury 1 1
Needle Stick/Puncture 1 1
Thromboembolism 1 1
Abrasion 1 1
Exposure to Body Fluids 1 1
Bruise/Contusion 1 1
Embolus 1 1
Hemorrhage/Bleeding 1 1
Miscarriage 1 1
Thrombosis 1 1
Ventricular Fibrillation 1 1
Misdiagnosis 1 1
Thrombosis/Thrombus 1 1
Insufficient Information 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
-
-