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TPLC
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show TPLC since
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Device
test, time, partial thromboplastin
Product Code
GGW
Regulation Number
864.7925
Device Class
2
Premarket Reviews
Manufacturer
Decision
ANIARA DIAGNOSTICA ,LLC
SUBSTANTIALLY EQUIVALENT
1
R2 DIAGNOSTICS, INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
2
2
2016
7
7
2017
15
15
2018
18
18
2019
3
3
2020
4
4
2021
4
4
2022
1
1
2024
4
4
Device Problems
MDRs with this Device Problem
Events in those MDRs
High Test Results
24
24
Adverse Event Without Identified Device or Use Problem
15
15
Low Test Results
12
12
Incorrect, Inadequate or Imprecise Result or Readings
4
4
Use of Device Problem
3
3
Manufacturing, Packaging or Shipping Problem
1
1
Device Operates Differently Than Expected
1
1
Off-Label Use
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
41
41
No Clinical Signs, Symptoms or Conditions
11
11
No Information
4
4
Coagulation Disorder
1
1
Intracranial Hemorrhage
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Siemens Healthcare Diagnostics, Inc.
II
Apr-09-2013
2
Siemens Healthcare Diagnostics, Inc.
II
Feb-16-2012
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