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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
Product CodeDIP
Regulation Number 862.3350
Device Class 2

MDR Year MDR Reports MDR Events
2019 25 25
2020 17 17
2021 49 49
2022 18 18
2023 42 42

Device Problems MDRs with this Device Problem Events in those MDRs
Low Test Results 71 71
High Test Results 66 66
No Apparent Adverse Event 42 42
Incorrect, Inadequate or Imprecise Result or Readings 13 13
Low Readings 4 4
Improper or Incorrect Procedure or Method 1 1
Use of Device Problem 1 1
High Readings 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 114 114
No Known Impact Or Consequence To Patient 30 30
No Consequences Or Impact To Patient 7 7

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