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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
Regulation Description Neuroleptic drugs radioreceptor assay test system.
Product CodeLEG
Regulation Number 862.3645
Device Class 2

MDR Year MDR Reports MDR Events
2016 25 25
2017 8 8
2018 24 24
2019 13 13
2020 9 9
2021 10 10

Device Problems MDRs with this Device Problem Events in those MDRs
Low Test Results 59 59
High Test Results 32 32
Incorrect, Inadequate or Imprecise Resultor Readings 7 7
Incorrect Or Inadequate Test Results 3 3
Incorrect Measurement 2 2
High Readings 2 2
Calibration Problem 1 1
Device Operates Differently Than Expected 1 1
Protective Measures Problem 1 1
Product Quality Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 71 71
No Clinical Signs, Symptoms or Conditions 12 12
No Consequences Or Impact To Patient 6 6

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