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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device calibrator, secondary
Regulation Description Calibrator.
Product CodeJIT
Regulation Number 862.1150
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 5
  1.  K032458  ABBOTT ARCHITECT ESTRADIOL CALIBRATORS; ABBOTT IMX ...
  2.  K053330  ARCHITECT B12 CALIBRATORS
  3.  K111023  ABBOTT ARCHITECT LH CALIBRATORS
  4.  K151566  Abbott ARCHITECT Total T4 Calibrators
  5.  K781423  DUAL COMPONENT STANDARDS
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 1
BAYER
  SUBSTANTIALLY EQUIVALENT 1
BECKMAN COULTER
  SUBSTANTIALLY EQUIVALENT 8
BIONOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
BOEHRINGER
  SUBSTANTIALLY EQUIVALENT 1
DADE BEHRING
  SUBSTANTIALLY EQUIVALENT 29
Diagnostic Chemicals Ltd.
  SUBSTANTIALLY EQUIVALENT 1
DIAGNOSTICA STAGO
  SUBSTANTIALLY EQUIVALENT 1
EMD
  SUBSTANTIALLY EQUIVALENT 3
FISHER
  SUBSTANTIALLY EQUIVALENT 1
GENZYME CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
Nichols Institute Diagnostics
  SUBSTANTIALLY EQUIVALENT 1
OLYMPUS
  SUBSTANTIALLY EQUIVALENT 4
ORTHO-CLINICAL
  SUBSTANTIALLY EQUIVALENT 4
ROCHE DIAGNOSTICS CORP.
  SUBSTANTIALLY EQUIVALENT 18
SIEMENS
  SUBSTANTIALLY EQUIVALENT 4

Device Problems
High test results 1
No Information 1
Total Device Problems 2

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 1 0 0 0 2 5 2 4 1 0
Class III 1 0 0 0 0 0 1 1 1 0

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Laboratories II May-29-2014
2 Beckman Coulter Inc. II Oct-10-2012
3 Beckman Coulter Inc. II Mar-20-2012
4 Beckman Coulter Inc. II May-20-2011
5 Beckman Coulter Inc. II May-10-2011
6 Bio-Rad Laboratories Inc II Jan-25-2007
7 Immunodiagnostics Systems Ltd II Oct-10-2012
8 Ortho-Clinical Diagnostics III Nov-02-2015
9 Ortho-Clinical Diagnostics II Jun-16-2014
10 Ortho-Clinical Diagnostics III Mar-12-2014
11 Ortho-Clinical Diagnostics II Feb-07-2012
12 Siemens Healthcare Diagnostics, Inc II Jun-06-2013
13 Siemens Healthcare Diagnostics, Inc. II Jan-08-2015
14 Siemens Healthcare Diagnostics, Inc. II Oct-06-2014
15 Siemens Healthcare Diagnostics, Inc. II Jun-26-2014
16 Siemens Healthcare Diagnostics, Inc. II Aug-07-2013
17 Siemens Healthcare Diagnostics, Inc. III Mar-25-2013
18 Siemens Healthcare Diagnostics, Inc. II Jan-11-2012
19 Wako Chemicals USA, Inc. III Jul-12-2007

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