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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
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 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 23 23
Contamination 14 14
Device Markings/Labelling Problem 3 3
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 40 40
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
3 Becton Dickinson & Co. II Aug-17-2018
4 Becton Dickinson & Co. II May-03-2013
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