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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device enzyme immunoassay, diphenylhydantoin
Regulation Description Diphenylhydantoin test system.
Product CodeDIP
Regulation Number 862.3350
Device Class 2

MDR Year MDR Reports MDR Events
2021 49 49
2022 18 18
2023 42 42
2024 5 5
2025 2 2
2026 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Low Test Results 63 63
High Test Results 51 51
No Apparent Adverse Event 42 42
Non Reproducible Results 3 3
Low Readings 1 1
Use of Device Problem 1 1
Improper or Incorrect Procedure or Method 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 117 117

Recalls
Manufacturer Recall Class Date Posted
1 Ortho-Clinical Diagnostics, Inc. II Feb-19-2021
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