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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 10
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 10

Device Problems
Incorrect or inadequate result 2224
Incorrect or inadequate test results 955
Improper device output 497
Low test results 262
High test results 233
Improper or incorrect procedure or method 44
Device Issue 11
Device displays error message 11
Unable to obtain readings 10
Replace 9
No Known Device Problem 9
Output above specifications 6
No Information 5
Unexpected therapeutic results 4
Use of Device Issue 4
Incorrect display 3
Electrical issue 2
Device expiration issue 2
Display misread 2
No display or display failure 2
False reading from device non-compliance 2
Nonstandard device or device component 2
Retraction problem 2
Shelf life exceeded 2
Device operates differently than expected 2
Human-Device Interface Issue 2
Expiration date error 2
No code available 1
Missing test results 1
Therapeutic or diagnostic output failure 1
Device markings issue 1
High Readings 1
Other (for use when an appropriate device code cannot be identified) 1
Inadequate service 1
Occlusion within device 1
Melted 1
Mislabeled 1
Overheating of device or device component 1
Product quality issue 1
Burn of device or device component 1
Use of Incorrect Control Settings 1
Corrosion 1
False negative result 1
Total Device Problems 4325

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 0 1 1 0
Class II 2 2 2 1 1 1 6 1 2 0
Class III 2 0 1 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Point Of Care Inc. II Aug-10-2015
2 Abbott Point Of Care Inc. II Dec-04-2013
3 Abbott Point Of Care Inc. II Aug-08-2012
4 Abbott Point of Care Inc. II Jul-13-2010
5 Abbott Point of Care Inc. II Jan-23-2007
6 Alere San Diego II Jun-24-2011
7 Alere San Diego, Inc. I Jan-03-2015
8 Alere San Diego, Inc. I May-08-2014
9 Assuramed II Sep-13-2013
10 Diagnostica Stago, Inc. II Dec-18-2008
11 Diagnostica Stago, Inc. III Jul-03-2007
12 Fisher Diagnostics, A Company of Fisher Scientific LLC II Jun-26-2015
13 HemoSense Inc III May-22-2009
14 Instrumentation Laboratory Co. II Dec-19-2014
15 Instrumentation Laboratory Co. II Jul-22-2013
16 International Technidyne Corp. II Feb-19-2013
17 International Technidyne Corp. III Jan-13-2007
18 International Technidyne Corporation II Jan-25-2008
19 Roche Diagnostics Corp. II Aug-11-2009
20 Roche Diagnostics Corp. II Apr-11-2007
21 Roche Diagnostics Operations, Inc. II Jun-24-2013
22 Roche Diagnostics Operations, Inc. II Apr-15-2013
23 Roche Diagnostics Operations, inc. II Sep-03-2009

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