Events

Alerte De Sécurité sur Etest Vancomycin / Teicoplamine X Polymyxin B, Registration No. 10158120623, lot: 1002338240 (Vancomycin / Teicoplamine) and lot 1002735070 (Polymyxin B).

Selon Agência Nacional de Vigilância Sanitária (ANVISA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Brazil qui a été fabriqué par BIOMÉRIEUX Brasil S.A.; BIOMERIEUX S.A.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • ID de l'événement
    1438
  • Date
    2014-10-03
  • Pays de l'événement
    Brazil
  • Source de l'événement
    ANVISA
  • URL de la source de l'événement
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    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.
  • Cause
    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