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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device plasma, coagulation control
Product CodeGGN
Regulation Number 864.5425
Device Class 2


Premarket Reviews
ManufacturerDecision
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
Use of Device Problem 14 14
Improper or Incorrect Procedure or Method 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
Missing Value Reason 1 1
Device Handling Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Laceration(s) 33 33
Injury 3 3
Needle Stick/Puncture 1 1
Postoperative refraction, unexpected 1 1
No Known Impact Or Consequence To Patient 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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