Events

Alerte De Sécurité sur HIV Test Bioeasy, Registration No. 10071770701, Lot 03AD15001-A

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 ALERE S.A.; Standard Diagnostics.

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
    1761
  • Date
    2015-12-01
  • 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
    Alere SA imports the Bioeasy HIV test kit in individual packaging for repackaging in Brazil. Exclusively for supply to the Ministry of Health, the company uses a package in addition to the actual packaging of the kit, ie the kit comes in two boxes
  • Cause
    The company reported that a part of lot 03ad15001-a, hiv kit 03fk10 was provided with the wrong secondary box label. in the secondary packaging, the label was printed wrongly quoting the alere hcv 02fk10 kit and not the bioeasy 03fk10 hiv test kit. the label on the outer carton (shipping box), the inner carton and the individual packaging of the kit are correct.
  • Action
    The company is performing the collection of the affected lot, I was distributed exclusively to the Ministry of Health.

Device

HIV Test Bioeasy, Registration No. 10071770701, Lot 03AD15001-A

Manufacturer

ALERE S.A.; Standard Diagnostics
  • Société-mère du fabricant (2017)
    Abbott Laboratories
  • Commentaire du fabricant
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    ANVSANVISA