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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 2017
22 22 49 46 124 127 46 46 38 46 46

Device Problems
No Known Device Problem 108
False positive result 77
False negative result 49
Incorrect or inadequate test results 26
High test results 22
Defective item 16
Low test results 15
Mechanical issue 7
Other (for use when an appropriate device code cannot be identified) 4
Unknown (for use when the device problem is not known) 1
Electrical issue 1
Incorrect or inadequate result 1
Sensitivity 1
Low readings 1
No code available 1
Total Device Problems 330

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