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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
2020 17 17
2021 49 49
2022 18 18
2023 42 42
2024 5 5
2025 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Low Test Results 66 66
High Test Results 64 64
No Apparent Adverse Event 42 42
Non Reproducible Results 2 2
Low Readings 2 2
High 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 121 121
No Known Impact Or Consequence To Patient 11 11
No Consequences Or Impact To Patient 1 1

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