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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 2226
Incorrect or inadequate test results 1078
Improper device output 497
High test results 314
Low test results 293
Improper or incorrect procedure or method 44
Device Issue 12
Device displays error message 11
Unable to obtain readings 10
No Known Device Problem 10
Replace 9
Output above specifications 6
Use of Device Issue 6
No Information 6
Unexpected therapeutic results 4
No display or display failure 4
Incorrect display 3
Burn of device or device component 3
Nonstandard device or device component 2
Electrical issue 2
Device expiration issue 2
False reading from device non-compliance 2
Retraction problem 2
Display misread 2
Shelf life exceeded 2
Expiration date error 2
Device operates differently than expected 2
Human-Device Interface Issue 2
No code available 1
Patient Data Issue 1
Missing test results 1
Therapeutic or diagnostic output failure 1
Not Applicable 1
Device markings issue 1
High Readings 1
Inadequate service 1
Other (for use when an appropriate device code cannot be identified) 1
Instruction for use issue 1
Melted 1
Mislabeled 1
False negative result 1
Occlusion within device 1
Use of Incorrect Control Settings 1
Corrosion 1
Overheating of device or device component 1
Product quality issue 1
Total Device Problems 4574

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 0 1 1 1
Class II 2 2 2 1 1 1 6 1 2 1
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 Aug-19-2016
8 Alere San Diego, Inc. I Jan-03-2015
9 Alere San Diego, Inc. I May-08-2014
10 Assuramed II Sep-13-2013
11 Diagnostica Stago, Inc. II Dec-18-2008
12 Diagnostica Stago, Inc. III Jul-03-2007
13 Fisher Diagnostics, A Company of Fisher Scientific LLC II Jun-26-2015
14 HemoSense Inc III May-22-2009
15 Instrumentation Laboratory Co. II Dec-19-2014
16 Instrumentation Laboratory Co. II Jul-22-2013
17 International Technidyne Corp. II Feb-19-2013
18 International Technidyne Corp. III Jan-13-2007
19 International Technidyne Corporation II Jan-25-2008
20 Roche Diagnostics Corp. II Aug-11-2009
21 Roche Diagnostics Corp. II Apr-11-2007
22 Roche Diagnostics Operations, Inc. II Nov-23-2016
23 Roche Diagnostics Operations, Inc. II Jun-24-2013
24 Roche Diagnostics Operations, Inc. II Apr-15-2013
25 Roche Diagnostics Operations, inc. II Sep-03-2009

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