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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
Product CodeLFX
Regulation Number 866.3510
Device Class 2

MDR Year MDR Reports MDR Events
2019 16 16
2020 21 21
2021 13 13
2022 13 13
2023 7 7
2024 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 23 23
False Negative Result 14 14
Incorrect, Inadequate or Imprecise Result or Readings 14 14
False Positive Result 12 12
No Apparent Adverse Event 5 5
Non Reproducible Results 4 4
Low Test Results 4 4

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 32 32
No Consequences Or Impact To Patient 20 20
No Known Impact Or Consequence To Patient 16 16
No Patient Involvement 3 3
No Information 1 1

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