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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
2020 29 29
2021 25 25
2022 3 3
2023 27 27
2024 1 1
2025 17 17

Device Problems MDRs with this Device Problem Events in those MDRs
Low Test Results 84 84
High Test Results 9 9
Insufficient Information 8 8
No Apparent Adverse Event 2 2
Incorrect, Inadequate or Imprecise Result or Readings 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 92 92
No Known Impact Or Consequence To Patient 10 10

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