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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device enzyme immunoassay, digitoxin
Regulation Description Digitoxin test system.
Product CodeLFM
Regulation Number 862.3300
Device Class 2

MDR Year MDR Reports MDR Events
2021 25 25
2022 3 3
2023 27 27
2024 1 1
2025 18 18

Device Problems MDRs with this Device Problem Events in those MDRs
Low Test Results 63 63
Insufficient Information 8 8
High Test Results 3 3
No Apparent Adverse Event 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 74 74

Recalls
Manufacturer Recall Class Date Posted
1 QUIDEL ORTHO II Jan-10-2025
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