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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device radioimmunoassay, estradiol
Regulation Description Estradiol test system.
Product CodeCHP
Regulation Number 862.1260
Device Class 1


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 1
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 1
BAYER
  SUBSTANTIALLY EQUIVALENT 1
BIOMERIEUX
  SUBSTANTIALLY EQUIVALENT 2
Bio-Rad Laboratories
  SUBSTANTIALLY EQUIVALENT 1
BOEHRINGER
  SUBSTANTIALLY EQUIVALENT 2
DIAGNOSTIC PRODUCTS
  SUBSTANTIALLY EQUIVALENT 5
ORGANON-TEKNIKA
  SUBSTANTIALLY EQUIVALENT 1
TERUMO CARDIOVASCULAR SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Incorrect or inadequate result 10
High test results 8
Incorrect or inadequate test results 7
Low test results 3
No Information 2
No code available 2
Mechanical issue 2
No Known Device Problem 1
Total Device Problems 35

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 0 0 0 0 4
Class III 1 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Laboratories II May-31-2016
2 Abbott Laboratories III Apr-07-2007
3 Beckman Coulter Inc. II Nov-23-2010
4 ORTHO-CLINICAL DIAGNOSTICS II Aug-05-2016
5 Roche Diagnostics Operations, Inc. II Mar-31-2016
6 Siemens Healthcare Diagnostics, Inc II Mar-24-2016

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