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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 38
High test results 22
False positive result 5
Incorrect or inadequate test results 4
Computer software issue 1
Imprecision 1
Performance 1
Low test results 1
Low readings 1
Device operates differently than expected 1
No Known Device Problem 1
Total Device Problems 76

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