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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device culture media, enriched
Regulation Description Enriched culture medium.
Product CodeKZI
Regulation Number 866.2330
Device Class 1

MDR Year MDR Reports MDR Events
2021 50 50
2022 41 41
2023 23 23
2024 11 11
2025 2713 2713

Device Problems MDRs with this Device Problem Events in those MDRs
Contamination 2547 2547
Incorrect, Inadequate or Imprecise Result or Readings 261 261
Contamination of Device Ingredient or Reagent 14 14
Device Markings/Labelling Problem 9 9
Chemical Problem 5 5
Device Ingredient or Reagent Problem 5 5
False Positive Result 2 2
Device Contamination with Chemical or Other Material 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2838 2838
No Consequences Or Impact To Patient 4 4

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