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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device enzymatic method, creatinine
Regulation Description Creatinine test system.
Product CodeJFY
Regulation Number 862.1225
Device Class 2


Premarket Reviews
ManufacturerDecision
BAYER
  SUBSTANTIALLY EQUIVALENT 1
BECKMAN COULTER
  SUBSTANTIALLY EQUIVALENT 2
BOEHRINGER
  SUBSTANTIALLY EQUIVALENT 4
DADE BEHRING
  SUBSTANTIALLY EQUIVALENT 1
Diagnostic Chemicals Ltd.
  SUBSTANTIALLY EQUIVALENT 1
EASTMAN KODAK
  SUBSTANTIALLY EQUIVALENT 1
MEDICAL SPECIALTIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
ORTHO-CLINICAL
  SUBSTANTIALLY EQUIVALENT 4
POLYMEDCO, INC.
  SUBSTANTIALLY EQUIVALENT 1
ROCHE DIAGNOSTICS CORP.
  SUBSTANTIALLY EQUIVALENT 2
SIEMENS
  SUBSTANTIALLY EQUIVALENT 2
THERMO ELECTRON
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
High test results 23
Low test results 23
Incorrect or inadequate test results 4
Device ingredient or reagent issue 1
Hole in material 1
Incorrect or inadequate result 1
Total Device Problems 53

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 2 1 2 2 1 1 1 2 1
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Abaxis Inc II Mar-16-2010
2 Dade Behring, Inc. II Dec-13-2008
3 Diagnostic Chemicals, Ltd. II Sep-30-2009
4 Ortho-Clinical Diagnostics II Apr-23-2014
5 Ortho-Clinical Diagnostics II Nov-15-2013
6 Polymer Technology Systems, Inc. II Jun-28-2012
7 Roche Diagnostics Corp. II Oct-09-2008
8 Roche Diagnostics Operations, Inc. II Jun-27-2015
9 Siemens Healthcare Diagnostics, Inc. II May-11-2016
10 Siemens Healthcare Diagnostics, Inc. II Sep-05-2015
11 Siemens Healthcare Diagnostics, Inc. II May-10-2011
12 Siemens Healthcare Diagnostics, Inc. II May-09-2011
13 Siemens Healthcare Diagnostics, Inc. II Sep-16-2010

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