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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device culture media, antimicrobial susceptibility test, mueller hinton agar/broth
Regulation Description Culture medium for antimicrobial susceptibility tests.
Product CodeJTZ
Regulation Number 866.1700
Device Class 2

MDR Year MDR Reports MDR Events
2021 20 20
2022 27 27
2023 20 20
2024 9 9
2025 20 20

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 59 59
Contamination 22 22
Contamination of Device Ingredient or Reagent 8 8
Microbial Contamination of Device 3 3
Device Markings/Labelling Problem 2 2
Low pH 1 1
Contamination /Decontamination Problem 1 1
Illegible Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 94 94
No Patient Involvement 1 1

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