Events

Alerte De Sécurité sur LIVES HBsAg ULTRA. Registered N °: 10158120583. Lot Affected: 820592901.

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 Biomerieux Brasil 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
    937
  • Date
    2008-08-02
  • 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
    Inside the kit are two silver packs containing the cones. In this case, some of the VIDAS HBsAg Ultra product packs were filled with VIDA CK-MB kit cones and labeled as VIDAS HBsAg Ultra.
  • Cause
    Some product units belonging to lot 820592901 were filled with material from a different diagnostic kit (vidas ck-mb) and labeled as vidas hbsag ultra.
  • Action
    Biomérieux Brasil SA has already started, through communication letters, the contact with the clients involved. The collection of affected products in Brazil has also been started by the company. The recommendations to the users are as follows: (1) for all the tests carried out with the product (of the lot under risk) and that presented NEGATIVE result, to contact the patients and to arrange a new test; (2) Immediately verify in stock the existence of lot no. 820592901 of the product; (3) If products of the batch in stock are located, segregate the products at risk and identify them immediately in order to avoid their use; (4) Contact the company through the Product Pickup Notification Letter; (5) Confirm, prior to the laboratory analysis and regardless of the batch number, whether the color of the BARRETE is the same as that of the CONE.

Device

LIVES HBsAg ULTRA. Registered N °: 10158120583. Lot Affected: 820592901.

Manufacturer

Biomerieux Brasil S.A.