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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
HAEMONETICS CORPORATION
  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

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 16 16
Use of Device Problem 14 14
High Test Results 11 11
Low Test Results 11 11
Insufficient Information 11 11
Adverse Event Without Identified Device or Use Problem 7 7
Incorrect Or Inadequate Test Results 6 6
Appropriate Term/Code Not Available 5 5
Improper or Incorrect Procedure or Method 5 5
Thermal Decomposition of Device 5 5
Incorrect Measurement 5 5
Output Problem 4 4
Data Problem 2 2
Electrical Shorting 2 2
Material Twisted/Bent 2 2
Use of Incorrect Control/Treatment Settings 2 2
Smoking 2 2
False Negative Result 2 2
Overheating of Device 2 2
Break 1 1
False Positive Result 1 1
Fire 1 1
Erratic or Intermittent Display 1 1
Charred 1 1
Computer Software Problem 1 1
Melted 1 1
Misconnection 1 1
Device Emits Odor 1 1
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

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 18 18
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
No Code Available 2 2
Aortic Dissection 2 2
Pulmonary Embolism 1 1
Abrasion 1 1
Thrombosis 1 1
Misdiagnosis 1 1
Hemorrhage/Bleeding 1 1
Thromboembolism 1 1
Bruise/Contusion 1 1
Embolus 1 1
Miscarriage 1 1
Injury 1 1
Needle Stick/Puncture 1 1
Blood Loss 1 1

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