Events

Safety Alert for Analyzer MULTIPLATE ROCHE

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Roche Diagnostics Gmbh.

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
    I1701-16
  • Event Number
    2012DM-0009209
  • Date
    2017-01-26
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=105
  • 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 reports that it has identified that the referenced analyzers can generate an incorrect reference range and a graphic impression of target range, when the customer defines any other paper size or orientation (horizontal) different to the a4 format, which could lead to delays in obtaining results of the analyzes carried out .

Device

Analyzer MULTIPLATE ROCHE
  • Model / Serial
  • Product Description
    MULTIPLATE roche analyzers are semi-automated equipment for the determination of multiple plaquetar function in patient blood samples. The instrument measures the activity of platelets when they are subjected to different stimuli of a chemical or physical type. The reagents that are used with the MULTIPLATE® rocket analyzer have respective health records.
  • Manufacturer
    Roche Diagnostics Gmbh

Manufacturer

Roche Diagnostics Gmbh