Events

Safety Alert for Accelerator A3600

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Inpeco S.P.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
    A1606-230
  • Event Number
    2013DM-0010218
  • Date
    2016-06-02
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=138
  • 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 manufacturer informs that he has received a statement from the distributor of the centrifugationreferenced module, in which he recommends immediately reducing the speed of the centrifugation and not exceeding the maximum speed of 3,500rpm, since changes in the material may affect the mechanical strength of the rotor vessels. therefore it could leave its housing in the centrifuge, which may lead to potentially serious adverse events occurring to the user.

Device

Accelerator A3600
  • Model / Serial
    Concerning the centrifugation module reference 06P37.
  • Product Description
    Designed to automate pre-analytical and post-analytical processing, in order to automate the processing of samples in the laboratory
  • Manufacturer
    Inpeco S.P.A.

Manufacturer

Inpeco S.P.A.