Events

Alerte De Sécurité sur Product name: Accelerator 3600 Technical name: CELL PREPARATION / SAMPLING EQUIPMENT FOR IN VITRO DIAGNOSIS Anvisa Registration Number: 80146501830 Hazard Class: I Affected Model: Not applicable Affected serial numbers: ACP009

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; Inpeco 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
    2171
  • Date
    2016-12-13
  • 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
    Customer Service or its representatives will visit the customer's location to replace the cables. Abbott will replace potentially non-compliant cables in the coming months. As parts are available, your Abbott service team will contact you to schedule replacement cables. Keep a copy of this statement in your lab files.
  • Cause
    Abbott diagnostics received the enclosed letter from inpeco, manufacturer of the accelerator a3600. you are receiving this notice because the products listed below may have been installed with a potentially non-compliant cable that could overheat. impacted specific cables connect the power distribution bus to the following modules: storage and retrieval module (srm) 9000; storage and retrieval module (srm) 15000; centrifuge module and i2000sr interface module.
  • Action
    Field Action Code FA27OCT2016 triggered under the responsibility of the company Abbott Laboratórios do Brasil LTDA. Company will make correction in the field.

Device

Product name: Accelerator 3600 Technical name: CELL PREPARATION / SAMPLING EQUIPMENT FOR IN VITRO...

Manufacturer

Abbott Laboratórios do Brasil; Inpeco S.A.
  • Source
    ANVSANVISA