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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device enzyme immunoassay, valproic acid
Product CodeLEG
Regulation Number 862.3645
Device Class 2

MDR Year MDR Reports MDR Events
2019 13 13
2020 9 9
2021 12 12
2022 19 19
2023 1 1
2024 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Low Test Results 38 38
High Test Results 35 35
Incorrect, Inadequate or Imprecise Result or Readings 2 2
High Readings 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 37 37
No Known Impact Or Consequence To Patient 19 19
No Consequences Or Impact To Patient 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Ortho-Clinical Diagnostics II Feb-19-2019
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