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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device culture media, non-selective and differential
Product CodeJSH
Regulation Number 866.2320
Device Class 1

MDR Year MDR Reports MDR Events
2021 42 42
2022 10 10
2023 8 8
2024 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 29 29
Contamination 23 23
Contamination of Device Ingredient or Reagent 3 3
Device Markings/Labelling Problem 2 2
Device Contaminated During Manufacture or Shipping 2 2
False Positive Result 2 2
Microbial Contamination of Device 1 1
Unclear Information 1 1
Missing Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 64 64
No Consequences Or Impact To Patient 3 3
No Patient Involvement 1 1

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