Events

Safety Alert for Automatic and Multiparameter Hematology Analyzer CELL DYN

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Abbott Diagnostics || Flextronics Manufacturing (Singapore) Pte Ltd.

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
    I1703-78
  • Event Number
    2008DM-0001607
  • Date
    2017-03-01
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=99
  • 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 detected that the medical-referenced device may have a printed circuit board (pcba) that may fail prematurely and lead to a loss of vacuum / pressure, suspending its operation and throwing one of the following error messages on the screen ( 0840, 1093, 1095, 1096, 0643 *, 0645 *), for which you must communicate with technical support, the team's delay could lead to delays in the sample processing times (* check that the reagent is not empty).

Device

Automatic and Multiparameter Hematology Analyzer CELL DYN

Manufacturer

Abbott Diagnostics || Flextronics Manufacturing (Singapore) Pte Ltd
  • Source
    NIDFSINVIMA