Events

Safety Alert for RETIC-COUNT (TIAZOL ORANGE)

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by BIOSCIENCES || Importer: BECKTON DICKINSON DE 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-020416
  • Event Number
    INVIMA 2008RD-0000754
  • Date
    2016-04-04
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=149
  • 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 information of the storage temperature that appears on the labels of the boxes of said batch is incorrect, finding a range of 2 ° c to 25 ° c, with a correct temperature of 2 ° c to 8 ° c. however, the information of the labels of the reagents, as well as the instructions of use, are correct, therefore, the probability of occurrence of damage resulting from this defect is low.

Device

RETIC-COUNT (TIAZOL ORANGE)

Manufacturer

BIOSCIENCES || Importer: BECKTON DICKINSON DE COLOMBIA LTDA
  • Source
    NIDFSINVIMA