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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device system, test, beta-2-microglobulin immunological
Regulation Description Beta-2-microglobulin immunological test system.
Product CodeJZG
Regulation Number 866.5630
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 2
BAYER
  SUBSTANTIALLY EQUIVALENT 2
BECKMAN COULTER
  SUBSTANTIALLY EQUIVALENT 1
BOEHRINGER
  SUBSTANTIALLY EQUIVALENT 1
DADE BEHRING
  SUBSTANTIALLY EQUIVALENT 2
DIAGNOSTIC PRODUCTS
  SUBSTANTIALLY EQUIVALENT 3
INSTRUMENTATION LABORATORY
  SUBSTANTIALLY EQUIVALENT 1
OLYMPUS
  SUBSTANTIALLY EQUIVALENT 1
ORGANON-TEKNIKA
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Device displays error message 37
Imprecision 8
Total Device Problems 45

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

Recalls
Manufacturer Recall Class Date Posted
1 Siemens Healthcare Diagnostics, Inc. II Mar-01-2016
2 Siemens Healthcare Diagnostics, Inc. II Aug-22-2015

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