Events

Safety Alert for NucliSENS® Lysis Buffer

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by BIOMERIEUX INC. || Imported by: 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
    IRD-020317.
  • Event Number
    INVIMA 2009RD-0001366
  • Date
    2017-03-21
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=96
  • 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
    The health agency informs that biomérieux, has confirmed other research that the eluate of the product referenced in the previous table, is colored due to the presence of the group hemode the hemoglobin present in samples of whole blood, including spot of dried blood. the presence of hemoglobin causes the inhibition of pcr, leading in most cases to non-interpretable results as it also inhibits internal control, invalidating the test, thus creating a potential risk related to possible false negative or delayed results. it has been confirmed that the root cause of the event is linked to the ph, which for lot 16092902, is 6.9 instead of 7.1 +/- 0.1, according to the product specification.

Device

NucliSENS® Lysis Buffer

Manufacturer

BIOMERIEUX INC. || Imported by: BIOMERIEUX COLOMBIA LTDA.