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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device test, hepatitis b (b core, be antigen, be antibody, b core igm)
Product CodeLOM
Device Class 3

Premarket Approvals (PMA)
2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
22 22 49 46 124 127 46 46 38 32

Device Problems
False positive result 66
No Known Device Problem 65
False negative result 38
Defective item 16
Incorrect or inadequate test results 16
High test results 13
Low test results 4
Other (for use when an appropriate device code cannot be identified) 4
Mechanical issue 4
Incorrect or inadequate result 1
Sensitivity 1
Unknown (for use when the device problem is not known) 1
Electrical issue 1
Low readings 1
Total Device Problems 231

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