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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device culture media, for isolation of pathogenic neisseria
Regulation Description Culture medium for pathogenic Neisseria spp.
Product CodeJTY
Regulation Number 866.2410
Device Class 2


Premarket Reviews
ManufacturerDecision
BIOMED DIAGNOSTICS INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 24 24
2022 11 11
2023 6 6
2024 6 6
2025 35 35

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 59 59
Contamination 16 16
Device Markings/Labelling Problem 4 4
Device Contaminated During Manufacture or Shipping 1 1
Microbial Contamination of Device 1 1
Contamination of Device Ingredient or Reagent 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 79 79
No Consequences Or Impact To Patient 3 3
No Patient Involvement 1 1
Insufficient Information 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Becton Dickinson & Co. II Dec-09-2022
2 Becton Dickinson & Co. II Apr-08-2021
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