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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 (BD)
  SUBSTANTIALLY EQUIVALENT 1
BECTON DICKINSON, AND COMPANY
  SUBSTANTIALLY EQUIVALENT 1
BECTON, DICKINSON AND COMPANY
  SUBSTANTIALLY EQUIVALENT 3
HARDY DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 15
OXOID LIMITED (PART OF THERMO FISHER SCIENTIFIC)
  SUBSTANTIALLY EQUIVALENT 7
  1.  K181975  Thermo Scientific Oxoid Meropenem/Vaborbactam Disc ...
  2.  K193508  Thermo Scientific Oxoid Eravacycline Disc (20ug) E ...
  3.  K203336  Thermo Scientific Oxoid Omadacycline Disc (30 ug) ...
  4.  K203700  Thermo Scientific Oxoid Cefiderocol Disc (30 µg) F ...
  5.  K210873  Thermo Scientific Oxoid Lefamulin Disc (20µg) LMU2 ...
  6.  K231806  Thermo Scientific Oxoid Rezafungin Disc (5 µg) RZF ...
  7.  K232276  Thermo Scientific Oxoid Sulbactam/Durlobactam Disc ...

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

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 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 17 17
No Consequences Or Impact To Patient 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Becton Dickinson & Co. II Feb-08-2024
2 Remel Inc II Jul-26-2021
3 Remel Inc II Dec-17-2015
4 Remel Inc II Mar-20-2014
5 Remel Inc II Jan-21-2014
6 Remel Inc II Jan-14-2014
7 Remel Inc III Dec-17-2013
8 Remel Inc III Aug-26-2013
9 Remel Inc II Feb-12-2013
10 Remel Inc II Feb-06-2013
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