Events

Recall of Device Recall Oxoid Antimicrobial Susceptability Testing Discs F300 (Nitrofurantoin)

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
    64852
  • Event Risk Class
    Class 3
  • Event Number
    Z-2081-2013
  • Event Initiated Date
    2013-03-25
  • Event Date Posted
    2013-08-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-06-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=117180
  • 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
    Use of affected lots may give false indication of susceptibility to nitrofurantoin.
  • Action
    ThermoFisher sent an Medical Device Recall letter dated March 18, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Please notify any personnel who needs notified of the potential for a false indication of susceptibility to Nitrofurantoin. Please review your inventory for affected product lots and discard the affected product. Return the attached Medical Device Recall Return Response acknowledging the disposal of the affected product. If you have any questions, please contact our Technical Services Department at 800-255-6730 (US) or 913- 888-0939 (International).

Device

Device Recall Oxoid Antimicrobial Susceptability Testing Discs F300 (Nitrofurantoin)
  • Model / Serial
    Lots 1194944 and 1198342
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Distribution including the states of AL, AR, CA, FL, GA, IL, KS, LA, MA, MD, NY, OK, PA, RI, TX, VA, and WA.
  • Product Description
    Oxoid Antimicrobial Susceptibility Test Discs F300 (Nitrofurantoin), Cat. #CT0036B, packaged in cartridges of 50 discs, 5 cartridges/pack. The firm name on the label is Oxoid Ltd., Basingstoke, Hampshire, England || Product is used in the semi-quantitative agar diffusion test method for in-vitro susceptibility testing.
  • 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