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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
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 8 8

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 38 38
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 73 73
No Patient Involvement 1 1

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