Events

Safety Alert for Access CEA (carcinoembryonic antigen)

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by BECKMAN COULTER || Imported by: ANALISIS TÉCNICOS LTDA Y ROCHEM || BIOCARE DE 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
    RRD-011115
  • Event Number
    INVIMA 2007RD-0000519
  • Date
    2015-11-03
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=168
  • 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
    Possible incorrect filling of the reagents in one of the wells, and therefore, there may be an insufficient amount of reagent. this report applies to the access range, which includes the access 2, unicel dxi 800, uniceldxi 600, unicel dxc immunoassay systems 600i, unicel dxc 880i, unicel dxc 860i, unicel dxc 680i and unicel dxc 660i.

Device

Access CEA (carcinoembryonic antigen)

Manufacturer

BECKMAN COULTER || Imported by: ANALISIS TÉCNICOS LTDA Y ROCHEM || BIOCARE DE COLOMBIA S.A.S