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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device enzyme linked immunoabsorbent assay, rubella
Regulation Description Rubella virus serological reagents.
Product CodeLFX
Regulation Number 866.3510
Device Class 2

MDR Year MDR Reports MDR Events
2020 21 21
2021 13 13
2022 13 13
2023 7 7
2024 13 13
2025 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 21 21
False Positive Result 17 17
False Negative Result 16 16
Incorrect, Inadequate or Imprecise Result or Readings 11 11
Low Test Results 6 6
Non Reproducible Results 3 3
Incorrect Measurement 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 45 45
No Consequences Or Impact To Patient 15 15
No Known Impact Or Consequence To Patient 8 8
No Patient Involvement 1 1

Recalls
Manufacturer Recall Class Date Posted
1 bioMerieux, Inc. II Dec-28-2021
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