Events

Safety Alert for EnVision FLEX+ MOUSE HIGH PH Link

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by DAKO INC. || Importer: ROCHEM BIOCARE.

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-040915
  • Event Number
    2012RD-0002265
  • Date
    2015-09-24
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=170
  • 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
    Failures in the manufacturing process of the lots related to this product recall that may lead to non-specific staining with false positive results.

Device

EnVision FLEX+ MOUSE HIGH PH Link
  • Model / Serial
    20019103 2 || 20019113 20 || 20020772 2 || 20020773 || 20023052
  • Product Description
    Determination of the different analytes related to samples from human origin
  • Manufacturer
    DAKO INC. || Importer: ROCHEM BIOCARE

Manufacturer

DAKO INC. || Importer: ROCHEM BIOCARE