Events

Safety Alert for REAGENTS R-GENE

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: BIOMERIEUX COLOMBIA S.A.S.

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-060516
  • Event Number
    INVIMA 2013RD-0002673 ; INVIMA 2013RD-0002694 ; INVIMA 2014RD-0002819 ; INVIMA 2016RD-0003529
  • Date
    2016-05-18
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=140
  • 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 use of these references in the rotorgene system is validated during the test using the consumable called "strips 4 tubes", however, the association between this consumable with the argene reagents has not been specified in the inserts of the referenced reagents. an internal study has confirmed that the interaction between other available rotorgene consumables can cause validation problems in control and / or internal control samples, demonstrating out-of-range results or illegible and nosigmoid curves as expected. for these reagents, there is a potential risk of causing delays in the results taking into account the incompatibility between the reagents and the consumables. for hsv2 reagents, the sensitivity of the test is reduced causing low positive results that can be interpreted as false negative results.

Device

REAGENTS R-GENE

Manufacturer

BIOMERIEUX S.A. || Importer: BIOMERIEUX COLOMBIA S.A.S