Events

Safety Alert for Panocell 10,16, 20

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by IMMUCOR INC. || Imported by: LABORATORIO DAI DE COLOMBIA S.A..

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-010317
  • Event Number
    INVIMA 2014RD-0002843.
  • Date
    2017-03-08
  • 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
    The sanitary agency notifies, that immucor issues the safety report regarding the typing of antigen v dedonantes e1011, where it was confirmed by dna tests that the cell # 11 of panocell-20, of lot 52872, of losdonantes e1011 confirmed with the antigen ( v-), instead of antigen (v +) as indicated in the master list, which has an impact on the reading of false negative results.

Device

Panocell 10,16, 20

Manufacturer

IMMUCOR INC. || Imported by: LABORATORIO DAI DE COLOMBIA S.A.