Events

Safety Alert for DISCUSSION OF SUSCEPTIBILITY TESTS TO CEFALOTEIN KF 30 (KF 30 CEPHALOTEHIN SUSCEPTIBILITY TEST DISKS)

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by OXOID LTD.

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
    153
  • Date
    2000-06-27
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 data from the U.S. and Brazil.
  • Extra notes in the data
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • Reason
    The aforementioned test discs have been labeled as a record of susceptibility tests on the cephalothionein, since the boxes contain titers of susceptibility to vancomycin. the distributor started a recall by dated correspondence of june 27, 2000. the company has provided no information to ecri.
  • Action
    MAKE SURE THAT YOU HAVE RECEIVED THE CORRESPONDENCE OF JUNE 27, 2000 FROM REMEL. IDENTIFY AND ISOLE ANY PRODUCT AFFECTED FROM YOUR INVENTORY. FOR FURTHER INFORMATION, PLEASE CONTACT YOUR LOCAL REMEL REPRESENTATIVE

Device

DISCUSSION OF SUSCEPTIBILITY TESTS TO CEFALOTEIN KF 30 (KF 30 CEPHALOTEHIN SUSCEPTIBILITY TEST DI...

Manufacturer

OXOID LTD
  • Source
    ANVSANVISA