Events

Safety Alert for Etest Vancomycin / Teicoplamine X Polymyxin B, Registration No. 10158120623, lot: 1002338240 (Vancomycin / Teicoplamine) and lot 1002735070 (Polymyxin B).

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by BIOMÉRIEUX Brasil S.A.; BIOMERIEUX 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
    1438
  • Date
    2014-10-03
  • 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
    According to the manifestation of the company, this does not compromise the quality of the product offered, but may negatively influence the susceptibility to antibiotics (Vancomycin / Teicoplamine and Polimixin B), which could lead to an incorrect or late antibiotic therapy decision. doctor responsible.
  • Reason
    The company holding the registration identified that there was a misunderstanding in the nationalization labeling of etest vancomycin / teicoplamine and polymyxin b. the vancomycin / teicoplamine products were labeled with the nationalization label containing the product polymyxin b. the company informs that both the printed boxes of both products, as the internal identification of the strips is correct. the problem occurred only in item nationalization labeling, affixed externally to products.
  • Action
    The company that holds the registration in Brazil informs that it has forwarded an explanatory letter to all the customers and distributors who acquired the affected lots, as detailed instructions on how to proceed with the products covered by this field action. The company advises customers and distributors to evaluate their inventory and if they have kits with the problem informed above, to interrupt these batches and return the Notification form to the Customer Service Department so that the recall can be scheduled.

Device

Etest Vancomycin / Teicoplamine X Polymyxin B, Registration No. 10158120623, lot: 1002338240 (Van...

Manufacturer

BIOMÉRIEUX Brasil S.A.; BIOMERIEUX S.A