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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device susceptibility test discs, antimicrobial
Product CodeJTN
Regulation Number 866.1620
Device Class 2


Premarket Reviews
ManufacturerDecision
BECTON DICKINSON, AND COMPANY
  SUBSTANTIALLY EQUIVALENT 1
BECTON, DICKINSON AND COMPANY
  SUBSTANTIALLY EQUIVALENT 1
HARDY DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 7
OXOID LIMITED (PART OF THERMO FISHER SCIENTIFIC)
  SUBSTANTIALLY EQUIVALENT 6

MDR Year MDR Reports MDR Events
2021 5 5
2022 5 5
2023 4 4
2024 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Device Markings/Labelling Problem 10 10
Incorrect, Inadequate or Imprecise Result or Readings 7 7
Inaccurate Information 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 18 18
No Consequences Or Impact To Patient 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Becton Dickinson & Co. II Dec-05-2024
2 Becton Dickinson & Co. II Feb-08-2024
3 Remel Inc II Jul-26-2021
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