Events

Recall of Device Recall Oxoid Gentamicin Anticrobial Susceptibility Testing Disc

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Remel Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    72525
  • Event Risk Class
    Class 2
  • Event Number
    Z-0443-2016
  • Event Initiated Date
    2015-11-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-02-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=141388
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Susceptibility test discs, antimicrobial - Product Code JTN
  • Reason
    Antibiotic concentration may be insufficient which may result in incorrect test results.
  • Action
    ThermoFisher Scientific sent an Urgent Medical Device Recall letter dated November 6, 2015, to all affected customers via first class mail. The recall notice identified the problem with the device and asked customers to inspect their stocks for the affected lots. The notice instructed customers to destroy any remaining inventory from the affected lots, contact the recalling firm for replacement, and complete the accompanying Acknowledgement form. Customers with questions were instructed to contact the Technical Services Departmentn at 800-255-6730 (US) or 913-888-0939 (International). For questions regarding this recall call 913-895-4077.

Device

Device Recall Oxoid Gentamicin Anticrobial Susceptibility Testing Disc
  • Model / Serial
    Lot 1686823, expiry 30 June 2018
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution including IL, GA, FL, NC, CA, AL, MA, IN, MO, NY, TX, VA, KS, and IA. Product was also distributed to Puerto Rico.
  • Product Description
    Oxoid Gentamicin Antimicrobial Susceptibility Testing Disc (CN10), REF# CT0024B packaged in packs of 5 cartridges - 50 disc/cartridge. || Used in the semi-quantitative agar diffusion test method for in vitro susceptibility testing to assist in the determination of a suitable antibiotic agent for treatment purposes.
  • Manufacturer
    Remel Inc

Manufacturer

Remel Inc
  • Manufacturer Address
    Remel Inc, 12076 Santa Fe Trail Dr, Lenexa KS 66215-3519
  • Manufacturer Parent Company (2017)
    Thermo Fisher Scientific Inc
  • Source
    USFDA