Events

Safety Alert for Oxoid Antimicrobial Susceptibility Testing Disc CN10 (Gentamicin)

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Thermo Fisher Scientific.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2013-05-10
  • Event Date Posted
    2013-05-10
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130510a.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: thermo fisher scientific oxoid antimicrobial susceptibility testing disc cn10 (gentamicin) medical device manufacturer, thermo fisher scientific issued a medical device safety alert concerning oxoid antimicrobial susceptibility testing disc cn10 (gentamicin) with model number ct0024b and lot number 1271724. according to the manufacturer, a technical investigation has indicated that cartridges of this lot of oxoid antimicrobial susceptibility testing disc cn10 (gentamicin), may contain individual discs that are not impregnated with antibiotic. continued use of this lot could result in false indication of resistance to gentamicin. the manufacturer advised the affected customers to: stop using this lot; destroy any remaining stock; review results reported using this lot; and consider retesting and/or seek appropriate expert advice. according to the manufacturer, the affected devices were distributed in hong kong. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 10 may 2013.

Device

Oxoid Antimicrobial Susceptibility Testing Disc CN10 (Gentamicin)
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Thermo Fisher Scientific Oxoid Antimicrobial Susceptibility Testing Disc CN10 (Gentamicin)
  • Manufacturer
    Thermo Fisher Scientific

Manufacturer

Thermo Fisher Scientific