Events

Recall Or Safety Alert for Systems VITEK 2 "antimicrobial susceptibility Test Kit AST-YS07 20 cards", different batches of catalog 414967 of antimicrobial sensitivity cards that include Flucytosine (FCT), for the detection of Candida krusei ATCC 6258.

According to Agencia Española de Medicamentos y Productos Sanitarios (Via FOI), this recall or safety alert involved a device in Spain that was produced by Biomérieux.

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
    Recall / Safety Alert
  • Date
    2015-06-17
  • Event Country
    Spain
  • Event Source
    AEMPSVFOI
  • Notes / Alerts
    The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, 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 Spain.
  • Extra notes in the data
  • Action
    Possible obtaining low quality control results (ORRL) of Flucytosine (FCT) for Candida krusei ATCC 6258 in VITEK 2 systems with certain Antimicrobial Sensitivity Cards (AST), manufactured by Biomérieux, USA.

Device

Systems VITEK 2 "antimicrobial susceptibility Test Kit AST-YS07 20 cards", different batches of c...

Manufacturer

Biomérieux