Events

Safety Alert for chromID S. aureus agar

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

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
    2013-08-08
  • Event Date Posted
    2013-08-08
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130808.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: biomérieux chromid s. aureus agar medical device manufacturer, biomérieux, has issued a medical device safety alert concerning certain lots of chromid s. aureus agar [catalogue no.: 43371; lot no.: all]. the manufacturer detected a sensitivity issue on chromid s. aureus agar (said) reference 43371: weak growth of staphylococcus aureus with a non-characteristic color at 24 hours from specimen samples or s. aureus atcc 25923 (quality control strain). the potential risk associated to this issue is reporting false negative results at 24 hours. as the package insert requires the identification of all colonies other than green ones (white, pink or mauve), s. aureus with a non-characteristic color will be systematically detected. according to the manufacturer’s investigation results, a modification of the package insert will be implemented. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 8 august 2013.

Device

chromID S. aureus agar
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: BioMérieux chromID S. aureus agar
  • Manufacturer
    BioMérieux

Manufacturer

BioMérieux