Events

Alerte De Sécurité sur Product name: Estradiol Life II Technical Name: Estradiol Life II ANVISA Registration Number: 10158120172 Hazard Class: I Affected Model: Affected serial numbers: Lot: 1004403350, 1004343690, 1004490710, 1004661480, 1004666000.

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.; bioMérieux 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
    2172
  • Date
    2016-08-12
  • 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
    1- Sending a letter to the usual customers / distributors of the product (Annex to this Notice) with the guidelines necessary to use the product. 2- See the step-by-step action plan that will be developed to notify all customers until the manufacturer includes in the instructions for use the risk of cross-reaction of the Vidas Estradiol II kit with the drug Fulvestrant.
  • Cause
    Biomérieux sa france manufacturer of the product vidas estradiol ii, was contacted by the national agency for the safety of medicines and products for health of france - ansm; to verify the occurrence of cross-reaction of the kit in question, or other kits for dosing estradiol, with the product fulvestrant. this request came from the fact that ansm was informed of this occurrence with a siemens healthcare company product. based on ansm's report, biomérieux sa opened an internal investigation (pr965756) and a study was carried out with the vidas family of equipment (vidas, mini-vidas and vidas3) together with the vidas estradiol ii kit, the only test for estradiol by biomérieux sa the investigation concluded that fulvestrant is cross-reactive with the vidas test. the cross-reactivity study done according to the principles of the clsi guide ep7-a2 "interference test in clinical chemistry" guide approved second edition, demonstrated that the cross-reactivity percentage obtained for fulvestrant is a maximum of 0.32% for a drug concentration of 20,000pg / ml.
  • Action
    Field Action Code FSCA 3039 triggered under the responsibility of the company bioMérieux Brasil SA Company will inform the clients.

Device

Product name: Estradiol Life II Technical Name: Estradiol Life II ANVISA Registration Number: 101...

Manufacturer

bioMérieux Brasil S.A.; bioMérieux S.A