Events

Alerte De Sécurité sur Rack Tray Technical name: Rack Tray, part of the equipment listed in the field action notification SBN-CPS-2016-013 ANVISA registration number: 3378900001 Hazard class: III

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 Roche Diagnóstica Brasil Ltda; Roche Diagnostics GmBH.

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
    2147
  • Date
    2016-10-07
  • 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
    Actions to be taken by the customer / user: 1) Please ensure that the updated racks cleaning procedure, attached to this field action notification as "Addendum - Cleaning Rack Mounts", shall be followed users / operators responsible for cleaning. 2) Please fill in the form contained at the end of this notification and send to email brasil.tecnovigilancia@roche.com For further questions and support, please do not hesitate to call our CEAC Service Center - 08007720295 of Roche Diagnóstica Brasil Ltda. #### Update of the field action: UPDATED ON 10/27/2017, the company presented the report of completion of the field action, with sending of necessary evidences and corrective actions.
  • Cause
    Recently, roche diagnostics learned of 5 cases of injuries (cuts of skin) caused by the edges of the racks during cleaning. due to this issue, an upgrade in the cleaning procedure of rack racks has become necessary. roche diagnostica notes that it is mandatory to follow this cleaning procedure, with instructions for safe handling of the parts, to avoid the risk of injury (edges or edges in the racks can cause cuts on the skin during the cleaning of the racks).
  • Action
    Field Action Code SBN-CPS-2016-013 triggered under the responsibility of the company Roche Diagnóstica Brasil Ltda. Company will update, correct or supplement the instructions for use.

Device

Rack Tray Technical name: Rack Tray, part of the equipment listed in the field action notificatio...

Manufacturer

Roche Diagnóstica Brasil Ltda; Roche Diagnostics GmBH