Events

Safety Alert for AD BIO PSA COMBO RAPID TEST I

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by CTK BIOTECH, INC. y BEIJING GENESEE BIOTECH INC. || Imported by: ANNAR DIAGNOSTICA IMPORT || 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
    RRD-010317
  • Event Number
    INVIMA 2013RD-0002459
  • Date
    2017-03-09
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=98
  • 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
    There is no evidence of the formation of the r (reference) line, which validates the interpretation of the test, this situation according to the researches carried out by the manufacturer based on the use of a different type of blood filter treated in the nitrocellulose membrane, the which was used in lot f0706m3d01.

Device

AD BIO PSA COMBO RAPID TEST I

Manufacturer

CTK BIOTECH, INC. y BEIJING GENESEE BIOTECH INC. || Imported by: ANNAR DIAGNOSTICA IMPORT || S...
  • Source
    NIDFSINVIMA