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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 2
  SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION 1
BAYER
  SUBSTANTIALLY EQUIVALENT 5
  SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION 1
BECKMAN COULTER
  SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION 2
BIOMERIEUX
  SUBSTANTIALLY EQUIVALENT 1
  SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION 1
BOEHRINGER
  SUBSTANTIALLY EQUIVALENT 6
DADE BEHRING
  SUBSTANTIALLY EQUIVALENT 3
  SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION 4
DIAGNOSTIC PRODUCTS
  SUBSTANTIALLY EQUIVALENT 2
FISHER
  SUBSTANTIALLY EQUIVALENT 1
  SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION 1
I-STAT
  SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION 1
ORTHO-CLINICAL
  SUBSTANTIALLY EQUIVALENT 1
  SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION 4
ROCHE DIAGNOSTICS CORP.
  SUBSTANTIALLY EQUIVALENT 1
  SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION 3

Device Problems
High test results 332
Defective item 87
Low test results 72
Incorrect or inadequate test results 58
False positive result 51
Imprecision 16
Incorrect or inadequate result 14
Sensitivity 10
False negative result 5
Unknown (for use when the device problem is not known) 4
Output, low 2
Output, high 2
Pumping issue 1
Malfunction 1
Use of Device Issue 1
Obstruction within device 1
Device displays error message 1
Incorrect measurement 1
Device inoperable 1
Total Device Problems 660

Recalls
  2007 2008 2009 2010 2011 2012 2013
Class I 2 0 1 0 0 1 0
Class II 1 2 2 5 3 4 1
Class III 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 Mar-18-2011
18 Siemens Healthcare Diagnostics, Inc. II Nov-24-2010
19 Siemens Healthcare Diagnostics, Inc. II Sep-11-2010
20 Siemens Healthcare Diagnostics, Inc. II Feb-25-2010
21 Siemens Healthcare Diagnostics, Inc. II Aug-12-2009
22 Siemens Medical Solutions Diagnostics II Jun-05-2008

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