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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device system,identification,hepatitis b antigen
Product CodeKSJ
Device Class 3

Device Problems
False negative result 58
Mechanical issue 49
False positive result 38
High test results 32
No Known Device Problem 19
Incorrect or inadequate test results 15
Low test results 8
Low readings 1
Device operates differently than expected 1
Imprecision 1
Performance 1
Device Issue 1
Computer software issue 1
Output issue 1
No Information 1
Total Device Problems 227

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