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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device susceptibility test powders, antimycobacterial
Product CodeMJA
Regulation Number 866.1640
Device Class 2

MDR Year MDR Reports MDR Events
2021 5 5
2022 10 10
2023 40 40

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 45 45
Contamination 5 5
False Positive Result 2 2
Device Markings/Labelling Problem 2 2
Non Reproducible Results 1 1
Contamination of Device Ingredient or Reagent 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 55 55

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