Events

Safety Alert for QIAsymphony DSP DNA Midi Kit, QIAsymphony DSP DNA Mini Kit, QIAsymphony DSP Virus/ Pathogen Midi kit

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by QUIGEN GMBH || Importer: QUIMIOLAB 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-060616
  • Event Number
    INVIMA 2015RD-0003343
  • Date
    2016-06-22
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=135
  • 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
    Some cartridges (reag cart) in these batches of kits contain a support incorrectly, there being a significantly larger "fixation protrusion" between the one and the channel of the reaction beads. the above can lead to reagent splashes during the perforation of the cartridge, the cancellation of the run by blocking the z movement during the same, and reagent splashes in the bar code of the cartridge, causing an inaccurate reading of the bar code.

Device

QIAsymphony DSP DNA Midi Kit, QIAsymphony DSP DNA Mini Kit, QIAsymphony DSP Virus/ Pathogen Midi kit
  • Model / Serial
    QIAsymphony DSP DNA Midi Kit: reference; 937255, lots || 154022089, 154018358, 154022492 154021509 || QIAsymphony DSP DNA Mini Kit: reference: 937236, lots: || 154023773, 154022318 || QIAsymphony DSP Virus / Pathogen Midi Kit: reference 937055, || lots: 154023436 154022323
  • Product Description
    DETERMINATION OF DIFFERENT ANALYTICS RELATED TO SAMPLES FROM THE HUMAN ORGANIZATION
  • Manufacturer
    QUIGEN GMBH || Importer: QUIMIOLAB S.A.S.

Manufacturer

QUIGEN GMBH || Importer: QUIMIOLAB S.A.S.
  • Manufacturer Parent Company (2017)
    QIAGEN N.V.
  • Source
    NIDFSINVIMA