Events

Safety Alert for AGAR CHROMID MRSA (MRSA)

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

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-020616
  • Event Number
    INVIMA 2007RD-0000448
  • Date
    2016-06-03
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=138
  • 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
    Changes in the appearance of the agar in the affected lots due to a failure in the sedimentation of the particles by defects of raw material, affecting the color of the agar and giving it a pale appearance. this aspect can sometimes be detected by the user before use. this problem has no impact on microbial growth, however the coloration of the small colonies can be delayed (colorless appearance after incubation 18h and pink or red color after 24 hours ). therefore, if this defect is not detected before use, colorless colonies may appear instead of pink or red after 18 hours of incubation, presenting the risk of misinterpretation of the result as small, colorless, negative colonies after 18h incubation. .

Device

AGAR CHROMID MRSA (MRSA)
  • Model / Serial
    Reference: 413050, Lot: 1004727550, 1004746750 || Reference: 413051, Lot: 1004746760
  • Product Description
    ISOLATION, SCREENING AND TRANSPORTATION OF MICROORGANISMS.
  • Manufacturer
    BIOMERIEUX S.A || Importer: BIO MERIEUX COLOMBIA

Manufacturer

BIOMERIEUX S.A || Importer: BIO MERIEUX COLOMBIA