Events

Recall of Device Recall Oxoid Vancomycin susceptibility discs, 30 mcg.

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
    67590
  • Event Risk Class
    Class 2
  • Event Number
    Z-1246-2014
  • Event Initiated Date
    2014-02-18
  • Event Date Posted
    2014-03-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-06-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=125796
  • 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
    Some of the discs may not be impregnated with the antibiotic.
  • Action
    ThermoFisher sent an Urgent Medical Device Recall letter dated February 18, 2014, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to notify any personnel who need to be notified of the potential for a false indication of resistance to Vancomycin. Customers were also instructed to review their inventory for the affected product and discard it. Customers should review results reported using this lot and consider retesting and/or seek appropriate expert advice. Return the attached Medical Device Recall Return Response acknowledging receipt of the notice and disposal of the affected product. If product was further distributed, customers should contact those entities, advise them of the situation and provide them with a copy of the letter. Customers with questions were instructed to contact the Technical Services Department at 800-255-6730 (US) and 913-888-0939 (International). For questions regarding this recal lcall 913-895-4185.

Device

Device Recall Oxoid Vancomycin susceptibility discs, 30 mcg.
  • Model / Serial
    Lot 1174497, exp. 2015/04
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    Oxoid Vancomycin 30 mcg, each cartridge contains 50 susceptibility discs, CT0058B. The firm name on the label is Oxoid Ltd., Basingstoke, Hampshire, England. || 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