Events

Safety Alert for Novo Link Polymer Detection System

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by LEICA BIOSYSTEMS || Importer: NOVO COLOMBIA LTDA.

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-040116
  • Event Number
    INVIMA 2010RD-0001583 / INVIMA 2011RD-0001856
  • Date
    2016-01-29
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=159
  • 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
    Manufacturing error that may result in inadequate staining. if the product is used in accordance with the instructions for use and with appropriate controls, the end user can identify incorrect stains, otherwise, it could lead to a failure in the diagnosis and classification of a neoplasm.

Device

Novo Link Polymer Detection System
  • Model / Serial
    Bond Polymer Refine Detection: Ref: DS9800 || CMV PROBE. Ref: P80614 || EBER PROBE Ref: P80589 || KAPPA PROBE. Ref: PB0645 || LAMBDA PROBE. Ref: P80669 || RNA NEGATIVE CONTROL PROBE. Ref. P80809 || RNA POSITIVE CONTROL PROBE. Ref. PI30785 || Lots: 42314, 42388, 42474, 42486, 42579, 42627, 42645, || 42683, 42852, 43050, 42499, 42780, 42570, 42823, 42555, || 42802. || Novo link Polymer Detection Kit: Ref: RE7280, lots: 406039270, || 406039398.
  • Product Description
    DETERMINATION OF RELATED ANALYTICS IN SAMPLES FROM THE HUMAN ORGANISM.
  • Manufacturer
    LEICA BIOSYSTEMS || Importer: NOVO COLOMBIA LTDA

Manufacturer

LEICA BIOSYSTEMS || Importer: NOVO COLOMBIA LTDA
  • Source
    NIDFSINVIMA