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TPLC
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show TPLC since
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2024
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Device
system, multipurpose for in vitro coagulation studies
Product Code
JPA
Regulation Number
864.5425
Device Class
2
Premarket Reviews
Manufacturer
Decision
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
False Negative Result
3
3
Output Problem
3
3
Thermal Decomposition of Device
3
3
Material Twisted/Bent
2
2
Use of Incorrect Control/Treatment Settings
2
2
High Test Results
2
2
Smoking
2
2
High Readings
1
1
Misassembly by Users
1
1
Misconnection
1
1
Break
1
1
Failure to Obtain Sample
1
1
Misassembly During Maintenance/Repair
1
1
Electrical Shorting
1
1
Device Emits Odor
1
1
Computer Software Problem
1
1
Melted
1
1
Overheating of Device
1
1
Temperature Problem
1
1
False Positive Result
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
Needle Stick/Puncture
1
1
Ventricular Fibrillation
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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