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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device kit, screening, urine
Product CodeJXA
Regulation Number 866.2660
Device Class 1

MDR Year MDR Reports MDR Events
2015 8 8
2016 9 9
2017 4 4
2018 6 6
2019 5 5
2020 15 15
2021 5 5
2022 5 5
2023 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 36 36
False Negative Result 9 9
Contamination /Decontamination Problem 6 6
Contamination 5 5
Detachment of Device or Device Component 1 1
Device Markings/Labelling Problem 1 1
Device Operates Differently Than Expected 1 1
Output Problem 1 1
False Positive Result 1 1
Incorrect Or Inadequate Test Results 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 33 33
No Consequences Or Impact To Patient 11 11
No Clinical Signs, Symptoms or Conditions 10 10
No Patient Involvement 4 4
No Code Available 1 1

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