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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 726
Incorrect or inadequate result 188
False positive result 99
Incorrect or inadequate test results 98
Low test results 94
Defective item 87
No Known Device Problem 68
Mechanical issue 50
Device operates differently than expected 29
Imprecision 16
False negative result 14
Sensitivity 10
Unknown (for use when the device problem is not known) 4
No Information 4
Device handling issue 3
Misassembled by Users 2
Use of Device Issue 2
Output, high 2
Output, low 2
False reading from device non-compliance 2
Air leak 1
False alarm 1
Clumping in device or device ingredient 1
Leak 1
Incorrect measurement 1
Device Issue 1
Malfunction 1
Obstruction within device 1
Inadequate service 1
Device inoperable 1
Device displays error message 1
Calibration issue 1
High Readings 1
Low readings 1
Pumping issue 1
Total Device Problems 1515

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 2
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 Jun-21-2016
19 Siemens Healthcare Diagnostics, Inc II Jul-23-2015
20 Siemens Healthcare Diagnostics, Inc II Jul-02-2014
21 Siemens Healthcare Diagnostics, Inc. II Jun-25-2015
22 Siemens Healthcare Diagnostics, Inc. II Dec-12-2014
23 Siemens Healthcare Diagnostics, Inc. II Mar-18-2011
24 Siemens Healthcare Diagnostics, Inc. II Nov-24-2010
25 Siemens Healthcare Diagnostics, Inc. II Sep-11-2010
26 Siemens Healthcare Diagnostics, Inc. II Feb-25-2010
27 Siemens Healthcare Diagnostics, Inc. II Aug-12-2009
28 Siemens Medical Solutions Diagnostics II Jun-05-2008

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