Events

Safety Alert for Xpert EV (enterovirus) Assay

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by CEPHEID || Importer: ROCHEM BIOCARE 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-100316
  • Event Number
    INVIMA 2008RD-0001050
  • Date
    2016-03-16
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=151
  • 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
    Reports from clients that have presented a greater number of results generated by the analyzer are called "detection of signal loss" (loss of detection signal, e5011). therefore, patient results are not generated when using this test.

Device

Xpert EV (enterovirus) Assay
  • Model / Serial
    Reference GXEV-100N-10; Lot 1000021106; cartridge 06304
  • Product Description
    THESE TWO PRODUCTS ARE EMPLOYED FOR THE IDENTIFICATION OF MICROORGANISMS RELEASED IN SAMPLES PROVIDED BY THE HUMAN ORGANIZATION
  • Manufacturer
    CEPHEID || Importer: ROCHEM BIOCARE COLOMBIA S.A.S.

Manufacturer

CEPHEID || Importer: ROCHEM BIOCARE COLOMBIA S.A.S.