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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device immunoassay method, troponin subunit
Regulation Description Creatine phosphokinase/creatine kinase or isoenzymes test system.
Product CodeMMI
Regulation Number 862.1215
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 3
BAYER
  SUBSTANTIALLY EQUIVALENT 6
BECKMAN COULTER
  SUBSTANTIALLY EQUIVALENT 4
BIOMERIEUX
  SUBSTANTIALLY EQUIVALENT 2
BOEHRINGER
  SUBSTANTIALLY EQUIVALENT 6
DADE BEHRING
  SUBSTANTIALLY EQUIVALENT 7
DIAGNOSTIC PRODUCTS
  SUBSTANTIALLY EQUIVALENT 2
FISHER
  SUBSTANTIALLY EQUIVALENT 2
I-STAT
  SUBSTANTIALLY EQUIVALENT 1
ORTHO-CLINICAL
  SUBSTANTIALLY EQUIVALENT 5
ROCHE DIAGNOSTICS CORP.
  SUBSTANTIALLY EQUIVALENT 4

Device Problems
High test results 508
False positive result 89
Incorrect or inadequate result 87
Defective item 87
Incorrect or inadequate test results 82
Low test results 80
No Known Device Problem 37
Mechanical issue 34
Imprecision 16
Sensitivity 10
False negative result 9
Unknown (for use when the device problem is not known) 4
No Information 3
Output, high 2
Output, low 2
Use of Device Issue 2
False reading from device non-compliance 2
Device operates differently than expected 1
False alarm 1
Clumping in device or device ingredient 1
Device inoperable 1
Obstruction within device 1
Incorrect measurement 1
Device displays error message 1
Pumping issue 1
Malfunction 1
Total Device Problems 1063

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 2 0 1 0 0 1 0 0 0 0
Class II 1 2 2 5 3 4 1 2 2 1
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Laboratories II May-10-2012
2 Abbott Laboratories II Apr-15-2009
3 Abbott Laboratories II Jul-11-2007
4 Abbott Laboratories MPG I Jun-14-2007
5 Abbott Point Of Care Inc. II Aug-22-2012
6 Abbott Point Of Care Inc. II Aug-09-2012
7 Abbott Point Of Care Inc. II Nov-10-2011
8 Abbott Point of Care Canada Limited II Jan-24-2013
9 Alere San Diego II Apr-26-2012
10 Beckman Coulter Inc II Mar-19-2008
11 Beckman Coulter Inc. II Apr-04-2011
12 Beckman Coulter Inc. II Jul-12-2010
13 Beckman Coulter Inc. II Apr-12-2010
14 Biosite Inc I May-08-2009
15 Ortho-Clinical Diagnostics I May-26-2007
16 Roche Diagnostics Operations, Inc. I Apr-11-2012
17 Siemens Healthcare Diagnostics Inc II Jan-07-2016
18 Siemens Healthcare Diagnostics, Inc II Jul-23-2015
19 Siemens Healthcare Diagnostics, Inc II Jul-02-2014
20 Siemens Healthcare Diagnostics, Inc. II Jun-25-2015
21 Siemens Healthcare Diagnostics, Inc. II Dec-12-2014
22 Siemens Healthcare Diagnostics, Inc. II Mar-18-2011
23 Siemens Healthcare Diagnostics, Inc. II Nov-24-2010
24 Siemens Healthcare Diagnostics, Inc. II Sep-11-2010
25 Siemens Healthcare Diagnostics, Inc. II Feb-25-2010
26 Siemens Healthcare Diagnostics, Inc. II Aug-12-2009
27 Siemens Medical Solutions Diagnostics II Jun-05-2008

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