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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device system, multipurpose for in vitro coagulation studies
Regulation Description Multipurpose system for in vitro coagulation studies.
Product CodeJPA
Regulation Number 864.5425
Device Class 2


Premarket Reviews
ManufacturerDecision
  SUBSTANTIALLY EQUIVALENT 1
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 1
BIOMERIEUX
  SUBSTANTIALLY EQUIVALENT 2
BOEHRINGER
  SUBSTANTIALLY EQUIVALENT 3
DADE BEHRING
  SUBSTANTIALLY EQUIVALENT 12
DIAGNOSTICA STAGO
  SUBSTANTIALLY EQUIVALENT 3
INSTRUMENTATION LABORATORY
  SUBSTANTIALLY EQUIVALENT 9
INTERNATIONAL TECHNIDYNE CORP.
  SUBSTANTIALLY EQUIVALENT 9
MEDICAL DEVICE CONSULTANTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ORGANON-TEKNIKA
  SUBSTANTIALLY EQUIVALENT 5
PALL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
ROCHE DIAGNOSTICS CORP.
  SUBSTANTIALLY EQUIVALENT 2
SYSMEX
  SUBSTANTIALLY EQUIVALENT 3
TRINITY
  SUBSTANTIALLY EQUIVALENT 1
WARNER-LAMBERT CO.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Incorrect or inadequate result 1708
Measurements, inaccurate 223
Improper device output 207
Replace 48
High test results 46
Low test results 20
Incorrect or inadequate test results 20
Other (for use when an appropriate device code cannot be identified) 15
No Known Device Problem 8
Incorrect display 7
Output above specifications 4
Smoking 4
Inadequate training 2
Improper or incorrect procedure or method 2
False reading from device non-compliance 2
Inadequate instructions for healthcare professional 2
Device maintenance issue 2
Melted 2
Device handling issue 2
Low readings 1
Maintenance does not comply to manufacturers recommendations 1
No device output 1
User used incorrect product for intended use 1
Electrical issue 1
Use of Device Issue 1
Total Device Problems 2330

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 0 0 0 0
Class II 0 1 0 2 3 2 1 1 2 2
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Accriva Diagnostics Inc., dba ITC, dba Accumetrics II May-25-2016
2 Diagnostica Stago, Inc. II Nov-06-2012
3 Haemonetics Corporation II Feb-19-2015
4 Haemonetics Corporation II Jul-24-2013
5 Haemoscope Division of Haemonetics Corp II Jul-06-2011
6 Haemoscope Division of Haemonetics Corp II Mar-21-2011
7 ITC-Nexus Dx II Jul-21-2014
8 Inotech Biosystems Intl., Inc II Feb-07-2008
9 Instrumentation Laboratory Co. II Dec-27-2010
10 International Technidyne Corp. II Aug-05-2011
11 Medtronic Inc. Cardiac Rhythm Disease Managment II May-04-2010
12 Siemens Healthcare Diagnostics, Inc. II Feb-19-2016
13 Siemens Healthcare Diagnostics, Inc. II Jun-26-2012
14 TEM Systems Inc II Apr-03-2015

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