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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device test, time, prothrombin
Regulation Description Prothrombin time test.
Product CodeGJS
Regulation Number 864.7750
Device Class 2


Premarket Reviews
ManufacturerDecision
  SUBSTANTIALLY EQUIVALENT 1
ABBOTT
  SUBSTANTIALLY EQUIVALENT 1
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 3
BIOMERIEUX
  SUBSTANTIALLY EQUIVALENT 1
BOEHRINGER
  SUBSTANTIALLY EQUIVALENT 2
DADE BEHRING
  SUBSTANTIALLY EQUIVALENT 2
INSTRUMENTATION LABORATORY
  SUBSTANTIALLY EQUIVALENT 6
  SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION 3
INTERNATIONAL TECHNIDYNE CORP.
  SUBSTANTIALLY EQUIVALENT 8
I-STAT
  SUBSTANTIALLY EQUIVALENT 1
JOHNSON & JOHNSON
  SUBSTANTIALLY EQUIVALENT 2
KENDALL
  SUBSTANTIALLY EQUIVALENT 1
NOVA
  SUBSTANTIALLY EQUIVALENT 1
ORGANON-TEKNIKA
  SUBSTANTIALLY EQUIVALENT 5
PACIFIC HEMOSTASIS
  SUBSTANTIALLY EQUIVALENT 5
ROCHE DIAGNOSTICS CORP.
  SUBSTANTIALLY EQUIVALENT 6
  SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION 4

Device Problems
Incorrect or inadequate result 2035
Improper device output 497
Replace 9
Incorrect or inadequate test results 8
Unable to obtain readings 7
Output above specifications 6
Device displays error message 3
Incorrect display 3
Device expiration issue 2
Electrical issue 2
No Known Device Problem 2
Retraction problem 2
Use of Device Issue 1
Other (for use when an appropriate device code cannot be identified) 1
Expiration date error 1
False reading from device non-compliance 1
Therapeutic or diagnostic output failure 1
High test results 1
Shelf life exceeded 1
Overheating of device or device component 1
Mislabeled 1
Device markings issue 1
Improper or incorrect procedure or method 1
Melted 1
Total Device Problems 2588

Recalls
  2007 2008 2009 2010 2011 2012 2013
Class I 0 0 0 0 0 0 0
Class II 2 2 2 1 1 1 2
Class III 2 0 1 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Point Of Care Inc. II Aug-08-2012
2 Abbott Point of Care Inc. II Jul-13-2010
3 Abbott Point of Care Inc. II Jan-23-2007
4 Alere San Diego II Jun-24-2011
5 Diagnostica Stago, Inc. II Dec-18-2008
6 Diagnostica Stago, Inc. III Jul-03-2007
7 HemoSense Inc III May-22-2009
8 International Technidyne Corp. II Feb-19-2013
9 International Technidyne Corp. III Jan-13-2007
10 International Technidyne Corporation II Jan-25-2008
11 Roche Diagnostics Corp. II Aug-11-2009
12 Roche Diagnostics Corp. II Apr-11-2007
13 Roche Diagnostics Operations, Inc. II Apr-15-2013
14 Roche Diagnostics Operations, inc. II Sep-03-2009

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