Events

Alerte De Sécurité sur Technopath Multichem IA Plus, registration: 80146501893, Class of Risk: III - high risk product to individual and / or medium to public health, serial number / lot: 33505140.

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 ABBOTT LABORATÓRIOS DO BRASIL LTDA.; TECHNO-PATH MANUFACTURING LTDA..

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
    1560
  • Date
    2015-04-02
  • 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
    The stability specifications of the opened bottle in the Instructions for Use written in Portuguese do not apply to lot 33505140.
  • Cause
    02 problems were recorded: incorrect instruction resulting in an error in the stability specifications of the open bottle; the process of suitability was carried out outside the appropriate temperature conditions, i.E. at a temperature of -20 ° c or below. the consequence of subjecting the product to a partial freeze-thaw cycle is the change in its performance.
  • Action
    The registration holder advises customers to discontinue use of the product in accordance with laboratory procedures and forward letter to the company to arrange for the product to be collected.

Device

Technopath Multichem IA Plus, registration: 80146501893, Class of Risk: III - high risk product t...

Manufacturer

ABBOTT LABORATÓRIOS DO BRASIL LTDA.; TECHNO-PATH MANUFACTURING LTDA.
  • Source
    ANVSANVISA