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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device radioimmunoassay, parathyroid hormone
Regulation Description Parathyroid hormone test system.
Product CodeCEW
Regulation Number 862.1545
Device Class 2


Premarket Reviews
ManufacturerDecision
BECKMAN COULTER
  SUBSTANTIALLY EQUIVALENT 1
Bio-Rad Laboratories
  SUBSTANTIALLY EQUIVALENT 1
DIAGNOSTIC PRODUCTS
  SUBSTANTIALLY EQUIVALENT 10
DIASORIN
  SUBSTANTIALLY EQUIVALENT 3
Nichols Institute Diagnostics
  SUBSTANTIALLY EQUIVALENT 13
ORTHO-CLINICAL
  SUBSTANTIALLY EQUIVALENT 1
ROCHE DIAGNOSTICS CORP.
  SUBSTANTIALLY EQUIVALENT 3
SCANTIBODIES
  SUBSTANTIALLY EQUIVALENT 10
SIEMENS
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
High test results 25
No Known Device Problem 19
Low test results 8
Incorrect or inadequate test results 8
Mechanical issue 2
Computer operating system issue 1
No code available 1
Device handling issue 1
Total Device Problems 65

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

Recalls
Manufacturer Recall Class Date Posted
1 Beckman Coulter Inc. II Dec-09-2010
2 Beckman Coulter Inc. II Oct-20-2010
3 Roche Diagnostics Corp. II May-16-2007
4 Siemens Healthcare Diagnostics, Inc III Nov-06-2013
5 Siemens Healthcare Diagnostics, Inc II Jun-06-2013
6 Siemens Healthcare Diagnostics, Inc II Mar-07-2012

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