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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device calibrator, multi-analyte mixture
Regulation Description Calibrator.
Product CodeJIX
Regulation Number 862.1150
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 3
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 4
BAYER
  SUBSTANTIALLY EQUIVALENT 6
BECKMAN COULTER
  SUBSTANTIALLY EQUIVALENT 3
Bio-Rad Laboratories
  SUBSTANTIALLY EQUIVALENT 1
BOEHRINGER
  SUBSTANTIALLY EQUIVALENT 8
DADE BEHRING
  SUBSTANTIALLY EQUIVALENT 18
Diagnostic Chemicals Ltd.
  SUBSTANTIALLY EQUIVALENT 3
DIAGNOSTICA STAGO
  SUBSTANTIALLY EQUIVALENT 1
EMD
  SUBSTANTIALLY EQUIVALENT 1
FISHER
  SUBSTANTIALLY EQUIVALENT 1
INSTRUMENTATION LABORATORY
  SUBSTANTIALLY EQUIVALENT 4
NOVA
  SUBSTANTIALLY EQUIVALENT 2
OLYMPUS
  SUBSTANTIALLY EQUIVALENT 4
ORTHO-CLINICAL
  SUBSTANTIALLY EQUIVALENT 2
  SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION 1
RAICHEM
  SUBSTANTIALLY EQUIVALENT 1
ROCHE DIAGNOSTICS CORP.
  SUBSTANTIALLY EQUIVALENT 22
SIEMENS
  SUBSTANTIALLY EQUIVALENT 3

Device Problems
Low test results 150
High test results 94
High Readings 77
Calibration error 50
Malfunction 31
Miscalibration 31
Incorrect or inadequate test results 7
Failure to recalibrate 2
Failure to calibrate 1
Low readings 1
Total Device Problems 444

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

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Laboratories Inc. II Feb-06-2009
2 Abbott Laboratories Inc. II Jan-12-2009
3 Beckman Coulter Inc. III Oct-22-2012
4 Cargille-Sacher Laboratories Inc. III Dec-01-2009
5 Diagnostic Chemicals, Ltd. III Feb-27-2007
6 Mega Diagnostics III Apr-14-2007
7 Ortho-Clinical Diagnostics III May-17-2013
8 Ortho-Clinical Diagnostics II Mar-22-2012
9 Ortho-Clinical Diagnostics II Jan-27-2012
10 Roche Diagnostics Corp. II Jan-06-2009
11 Roche Diagnostics Corp. II Dec-29-2007
12 Siemens Healthcare Diagnostics, Inc. III Sep-09-2010
13 Siemens Healthcare Diagnostics, Inc. II May-04-2010
14 Siemens Healthcare Diagnostics, Inc. II Feb-26-2010

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