Events

Safety Alert for Sample preparation system VERSANT Kpcr. VERSANT HIV-1 RNA 1.0 ASSAY (KPCR) BOX 1 AND 2VERSANT HBV DNA 1.0 ASSAY (kPCR)

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by ROCHE MOLECULAR SYSTEMS || Importer: PRODUCTOS ROCHE 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-040416
  • Event Number
    INVIMA 2015RD-0001609-R1 ; INVIMA 2014RD-0002972
  • Date
    2016-04-19
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=146
  • 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
    Unexpected behavior of the software installed in the system. according to the instructions for use of the versant tests, in the "interpretation of results" section, the correct behavior of the software is to invalidate a result when the internal control for this well shows an error of "absence of the baseline", for this case, the test must be repeated. however, it has been observed that when presenting this error of the baseline in the internal control, the result of the test is not invalidated. this malfunction allows the possibility of generating incorrect values to be valid by the system.

Device

Sample preparation system VERSANT Kpcr. VERSANT HIV-1 RNA 1.0 ASSAY (KPCR) BOX 1 AND 2VERSANT HBV...

Manufacturer

ROCHE MOLECULAR SYSTEMS || Importer: PRODUCTOS ROCHE S.A