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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 38
False positive result 37
High test results 32
No Known Device Problem 17
Incorrect or inadequate test results 14
Low test results 5
Low readings 1
Device operates differently than expected 1
Imprecision 1
Performance 1
Device Issue 1
Computer software issue 1
Output issue 1
Total Device Problems 208

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