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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device radioimmunoassay, thyroid-stimulating hormone
Regulation Description Thyroid stimulating hormone test system.
Product CodeJLW
Regulation Number 862.1690
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 11
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 2
BAYER
  SUBSTANTIALLY EQUIVALENT 1
BECKMAN COULTER
  SUBSTANTIALLY EQUIVALENT 2
BIOMERIEUX
  SUBSTANTIALLY EQUIVALENT 1
Bio-Rad Laboratories
  SUBSTANTIALLY EQUIVALENT 9
BOEHRINGER
  SUBSTANTIALLY EQUIVALENT 3
DADE BEHRING
  SUBSTANTIALLY EQUIVALENT 1
DIAGNOSTIC PRODUCTS
  SUBSTANTIALLY EQUIVALENT 8
DIASORIN
  SUBSTANTIALLY EQUIVALENT 2
EASTMAN KODAK
  SUBSTANTIALLY EQUIVALENT 1
Nichols Institute Diagnostics
  SUBSTANTIALLY EQUIVALENT 3
OLYMPUS
  SUBSTANTIALLY EQUIVALENT 1
ORGANON-TEKNIKA
  SUBSTANTIALLY EQUIVALENT 1
ORTHO-CLINICAL
  SUBSTANTIALLY EQUIVALENT 2
ROCHE DIAGNOSTICS CORP.
  SUBSTANTIALLY EQUIVALENT 1
SCANTIBODIES
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS
  SUBSTANTIALLY EQUIVALENT 3
TERUMO CARDIOVASCULAR SYSTEMS
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Low test results 72
High test results 71
Incorrect or inadequate test results 55
Incorrect or inadequate result 4
High Readings 2
No Known Device Problem 1
No code available 1
Malfunction 1
Output, low 1
Total Device Problems 208

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

Recalls
Manufacturer Recall Class Date Posted
1 PerkinElmer LAS, Inc II Jan-11-2012
2 Perkinelmer II Aug-01-2012
3 Siemens Healthcare Diagnostics III Jan-07-2013
4 Siemens Healthcare Diagnostics, Inc II May-23-2014
5 Siemens Healthcare Diagnostics, Inc II Aug-06-2013
6 Siemens Healthcare Diagnostics, Inc. II Jul-21-2016
7 Siemens Healthcare Diagnostics, Inc. II Jun-04-2015
8 Siemens Healthcare Diagnostics, Inc. II Nov-24-2010
9 ThyroTec Inc III Mar-22-2007

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