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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 6
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 19
SIEMENS
  SUBSTANTIALLY EQUIVALENT 4

Device Problems
Low test results 3
No Known Device Problem 2
High test results 2
No Information 1
Use of Device Issue 1
Device Issue 1
Total Device Problems 10

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 0 0 0 0 0 0
Class II 1 0 0 0 2 5 2 4 1 0 1
Class III 1 0 0 0 0 0 1 1 1 2 2

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 Feb-09-2017
9 Ortho-Clinical Diagnostics III Sep-15-2016
10 Ortho-Clinical Diagnostics III Nov-02-2015
11 Ortho-Clinical Diagnostics II Jun-16-2014
12 Ortho-Clinical Diagnostics III Mar-12-2014
13 Ortho-Clinical Diagnostics II Feb-07-2012
14 Siemens Healthcare Diagnostics, Inc II Apr-19-2017
15 Siemens Healthcare Diagnostics, Inc II Jun-06-2013
16 Siemens Healthcare Diagnostics, Inc. III Feb-16-2017
17 Siemens Healthcare Diagnostics, Inc. II Jan-08-2015
18 Siemens Healthcare Diagnostics, Inc. II Oct-06-2014
19 Siemens Healthcare Diagnostics, Inc. II Jun-26-2014
20 Siemens Healthcare Diagnostics, Inc. II Aug-07-2013
21 Siemens Healthcare Diagnostics, Inc. III Mar-25-2013
22 Siemens Healthcare Diagnostics, Inc. II Jan-11-2012
23 Tosoh Bioscience, Inc. III Jul-25-2016
24 Wako Chemicals USA, Inc. III Jul-12-2007

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