Events

Safety Alert for Envision FLEX, 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 || Importer: ROCHEM BIOCARE DE COLOMBIA.

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-071115
  • Event Number
    INVIMA 2012RD-0002265
  • Date
    2015-11-18
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=166
  • 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
    Defect in the buffer solution that is part of the formulation of one or two components of the kit, in particular, the polymer / hrp, when this reagent is used with the specific antibodies of the epstein-barr virus, the mum-1 protein, the wilms tumor (wt - 1) and smooth muscle actin a very strong specific or nonspecific staining is observed. specific stains can lead to false positive results.

Device

Envision FLEX, High pH (link)
  • Model / Serial
    Envision FLEX, High pH (link), K8023, lots 20020777 and || 20019097
  • Product Description
    Determination of the different related analytes in samples from the human body
  • Manufacturer
    DAKO || Importer: ROCHEM BIOCARE DE COLOMBIA

Manufacturer

DAKO || Importer: ROCHEM BIOCARE DE COLOMBIA