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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
Regulation Description Antimicrobial susceptibility test powder.
Product CodeMJA
Regulation Number 866.1640
Device Class 2

MDR Year MDR Reports MDR Events
2021 5 5
2022 10 10
2023 43 43
2024 164 164
2025 119 119

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 306 306
Contamination 5 5
False Positive Result 4 4
Device Markings/Labelling Problem 2 2
Contamination of Device Ingredient or Reagent 2 2
Non Reproducible Results 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 335 335
Insufficient Information 3 3
Bacterial Infection 3 3

Recalls
Manufacturer Recall Class Date Posted
1 Becton Dickinson & Co. II Jun-25-2025
2 Becton Dickinson & Co. II Aug-16-2024
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