Events

Safety Alert for Mueller Hinton Agar 2 + 5% Sheep Blood (MHS)

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by BioMérieux S.A || Importer: BIOMERIEUX COLOMBIA LTDA.

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
  • Event ID
    RRD-060316
  • Event Number
    INVIMA 2007RD-0000430
  • Date
    2017-03-11
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=97
  • Notes / Alerts
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 recall data from the U.S. and Colombia.
  • Extra notes in the data
  • Reason
    Possible contamination of this batch stored in stock before its incubation, this contamination can be identified by an increase of the α-hemolytic colonies in the depth of the agar and not on the surface. the strain involved in the contamination of these culture media has been identified as erysipelothrix rhusiopathiae, whose growth during incubation to perform conantibiotic inhibition tests could potentially lead to a misinterpretation of the results of these tests, generating strong resistance to antibiotics.

Device

Mueller Hinton Agar 2 + 5% Sheep Blood (MHS)

Manufacturer

BioMérieux S.A || Importer: BIOMERIEUX COLOMBIA LTDA