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TPLC
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show TPLC since
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Device
plasma, coagulation control
Product Code
GGN
Regulation Number
864.5425
Device Class
2
Premarket Reviews
Manufacturer
Decision
AALTO SCIENTIFIC LTD.
SUBSTANTIALLY EQUIVALENT
1
AFFINITY BIOLOGICALS INC.
SUBSTANTIALLY EQUIVALENT
3
CLINIQA CORPORATION
SUBSTANTIALLY EQUIVALENT
1
DADE BEHRING, INC.
SUBSTANTIALLY EQUIVALENT
1
DIAGNOSTICA STAGO, INC.
SUBSTANTIALLY EQUIVALENT
1
DIAGNOSTICS STAGO S.A.S.
SUBSTANTIALLY EQUIVALENT
1
GEORGE KING BIO-MEDICAL, INC.
SUBSTANTIALLY EQUIVALENT
1
INSTRUMENTATION LABORATORY
SUBSTANTIALLY EQUIVALENT
1
INSTRUMENTATION LABORATORY CO.
SUBSTANTIALLY EQUIVALENT
2
INTERNATIONAL TECHNIDYNE CORP.
SUBSTANTIALLY EQUIVALENT
1
MAINE STANDARDS COMPANY LLC
SUBSTANTIALLY EQUIVALENT
3
MAINE STANDARDS COMPANY, LLC
SUBSTANTIALLY EQUIVALENT
1
MEDTRONIC INC.
SUBSTANTIALLY EQUIVALENT
2
MDR Year
MDR Reports
MDR Events
2014
5
5
2015
10
10
2016
9
9
2017
11
11
2018
4
4
Device Problems
MDRs with this Device Problem
Events in those MDRs
Improper or Incorrect Procedure or Method
14
14
Use of Device Problem
14
14
Adverse Event Without Identified Device or Use Problem
13
13
Human Factors Issue
5
5
Break
1
1
Material Fragmentation
1
1
Material Puncture/Hole
1
1
Device Handling Problem
1
1
Missing Value Reason
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Laceration(s)
33
33
Injury
3
3
Postoperative refraction, unexpected
1
1
No Known Impact Or Consequence To Patient
1
1
Needle Stick/Puncture
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Aniara Diagnostica LLC
III
Sep-15-2022
2
Aniara Diagnostica LLC
III
Apr-17-2019
3
Diagnostica Stago, Inc.
II
Dec-23-2019
4
Diagnostica Stago, Inc.
II
Feb-16-2012
5
Instrumentation Laboratory Co.
II
Dec-16-2013
6
International Technidyne Corp.
II
Aug-10-2010
7
International Technidyne Corporation
II
Jul-28-2010
8
International Technidyne Corporation
II
Jun-11-2010
9
TEM Systems Inc
II
Mar-09-2016
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