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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device antigens, cf (including cf control), influenza virus a, b, c
Regulation Description Influenza virus serological reagents.
Product CodeGNX
Regulation Number 866.3330
Device Class 1

MDR Year MDR Reports MDR Events
2021 36 36
2022 32 32
2023 61 61
2024 3 3
2025 93 93

Device Problems MDRs with this Device Problem Events in those MDRs
False Positive Result 112 112
Incorrect, Inadequate or Imprecise Result or Readings 107 107
Device Contamination with Chemical or Other Material 4 4
False Negative Result 2 2
Device Markings/Labelling Problem 1 1
Expiration Date Error 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 225 225
No Consequences Or Impact To Patient 4 4

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