Events

Alerte De Sécurité sur COBAS P 512 PRE-ANALYTICAL SYSTEM Technical name: Instrument for the preparation and processing of samples - preanalytical phase ANVISA registration number: 10287411162 Hazard class: I Serial numbers affected: 64002616; 64002716; 64002816; 64002916; 64003016; 64003116; 64007017 (Roche stock)

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
    2312
  • Date
    2017-06-12
  • 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
    Verify that the Rotate Status Detection feature is used in accordance with the updated Operator's Manual. (update described in the field action notification letter).
  • Cause
    Roche diagnostics gmbh, manufacturer of the product, initiated this field action as it identified opportunities for improvements in the detection of rotation and re-labeling of the cobas p 512 pre-analytical system upon receipt of complaints from two customers reporting that non-standard samples - centrifuges were incorrectly identified as "centrifuged" by detecting the rotation state in the cobas p 512 (64x) preanalytic system. in investigating such complaints, roche diagnostica has identified that all documentation related to the state of rotation detection needs to be updated to reflect the correct use intended.
  • Action
    Field Action Code SBN-CPS-2017-010 triggered under the responsibility of the company Roche Diagnóstica Brasil Ltda. Company will make correction in the field.

Device

COBAS P 512 PRE-ANALYTICAL SYSTEM Technical name: Instrument for the preparation and processing o...

Manufacturer

Roche Diagnóstica Brasil Ltda; Roche Diagnostics GmBH