Events

Safety Alert for FLEX ® PREALB

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by SIEMENS HEALTHCARE DIAGNOSTIC || Imported by: SIEMENS S.A..

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-020916
  • Event Number
    INVIMA 2008RD-0001111
  • Date
    2016-09-07
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=123
  • 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
    The healthcare agency notifies that siemens healthcarediagnostics confirms and communicates that the flex® reagent prealbdimension vista, presented a percentage of deviation> 5%, at calibration point 6, which led to errors in the calibration of the prealb method. to solve this problem he carried out a calibration procedure, with an optimization of the test during the manufacturing phase of the reactants, thus reducing the probability of a potential calibration failure.

Device

FLEX ® PREALB

Manufacturer

SIEMENS HEALTHCARE DIAGNOSTIC || Imported by: SIEMENS S.A.
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    NIDFSINVIMA