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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device hepatitis a test (antibody and igm antibody)
Regulation Description Hepatitis A virus (HAV) serological assays.
Product CodeLOL
Regulation Number 866.3310
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION 2
Bio-Rad Laboratories
  SUBSTANTIALLY EQUIVALENT 2
DIASORIN
  SUBSTANTIALLY EQUIVALENT 2
  SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION 1
ORTHO-CLINICAL
  SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION 2
ROCHE DIAGNOSTICS CORP.
  SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION 1
SIEMENS
  SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION 1

Device Problems
False positive result 12
False negative result 5
Incorrect or inadequate test results 4
High test results 3
Low test results 1
Device operates differently than expected 1
Imprecision 1
Total Device Problems 27

Recalls
  2007 2008 2009 2010 2011 2012 2013
Class I 0 0 0 0 0 0 0
Class II 1 1 0 1 1 0 0
Class III 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Diagnostics International, Ltd. II May-19-2010
2 Abbott Laboratories II Jun-06-2011
3 Abbott Laboratories II Jul-11-2007
4 Siemens Medical Solutions Diagnostics II May-06-2008

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