Events

Safety Alert for N látex ASL

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMHB, || SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS INC. || Importer: SIEMENS HEALTHCARE DIAGNOSTICS || 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
    IRD-040816
  • Event Number
    INVIMA 2010RD-0001778
  • Date
    2016-08-23
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=125
  • 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
    Siemens healthcare diagnostics has received complaints from customers regarding the batches described in the previous table of the n latex asl reagent, where they have reported that the calibration curve is not reliable, so it is difficult to calibrate the assay, and as a consequence results can be generated they can affect the patient.

Device

N látex ASL

Manufacturer

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMHB, || SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS INC. |...
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    NIDFSINVIMA