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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
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 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 51 51
Contamination 46 46
Contamination of Device Ingredient or Reagent 13 13
Device Markings/Labelling Problem 7 7
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 120 120
No Consequences Or Impact To Patient 4 4

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