Events

Safety Alert for BRAHMS FREE BETA HCG KRYPTOR

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by BRAHMS || Importer: VELEZ LAB.

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-020316
  • Event Number
    INVIMA 2012RD-0002185
  • Date
    2017-03-03
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=98
  • 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
    An overestimation of the concentrations of hcglibres of the order of 10% is reported when samples of patients or diluted control samples are processed, leading to an interpretation at higher risk of trisomy 21 or lower risk of detrisomy 13/18, which may cause erroneous interpretation for the intake. of treatment decisions or additional investigations. in this context, the manufacturer recommends the use of these batches without dilution, for which the results of the tests are not affected.

Device

BRAHMS FREE BETA HCG KRYPTOR
  • Model / Serial
    Reference: 809,075. Lots: 09075 and 09073
  • Product Description
    DETERMINATION OF THE ANALYTICS RELATED TO SAMPLES FROM THE HUMAN ORGANISMS
  • Manufacturer
    BRAHMS || Importer: VELEZ LAB

Manufacturer

BRAHMS || Importer: VELEZ LAB