Events

Alerte De Sécurité sur First Response HIV 1-2 Identification Number: 80213250458 Risk Class: IV Affected Model: Not Applicable Serial Numbers Affected: First Response HIV 1-2 Lot 38 I 16 14 D validity 11/31/2015.

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 Resserv Comércio de Produtos Diagnósticos LTDA ME; Premier Medical Corporation Limited.

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
    2134
  • Date
    2016-08-05
  • 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
    Recommendation on the product is not used the laboratory perform an analysis for possible test repetitions with the new batch of the product.
  • Cause
    The manufacturer of the product first response hiv 1-2 card test lot 38i1614d identified a temperature variation in storage and transport and an accelerated stability study was performed for this lot. based on the investigations, it was confirmed that the aforementioned lot has a slight performance deterioration in relation to the sensitivity. this decrease in sensitivity was observed due to temperature variation in storage and transport.
  • Action
    Field Action Code 322 triggered under the responsibility of the company Resserv Comércio de Produtos Diagnósticos LTDA ME. Company will collect for Total Product Incineration.

Device

First Response HIV 1-2 Identification Number: 80213250458 Risk Class: IV Affected Model: Not Appl...

Manufacturer

Resserv Comércio de Produtos Diagnósticos LTDA ME; Premier Medical Corporation Limited
  • Source
    ANVSANVISA