Events

Alerte De Sécurité sur CHEMICAL SYSTEM VITROS 5,1 FUSION, Registration no. 80145900827, lots: See Annex 1 - Distribution list.

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 Johnson & Johnson do Brasil Ind. e Com. de Prod. para Saúde Ltda; Ortho-Clinical Diagnostics, Inc..

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
    1573
  • Date
    2015-05-04
  • 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 company informs that if this anomaly occurs, it is possible that the VITROS® 5,1 FS System processes samples with a cartridge other than the intended cartridge, leading to potential erroneous patient results.
  • Cause
    Ortho-clinical diagnostics, inc. (ocd) has confirmed two cases in which the vitros® microslide cartridge has not been correctly identified. both cases occurred when an operator accessed slide supply 1 (ss1) before the green indicator light came on and then continued loading a dry reaction cartridge into slide supply 2. in both cases, the cartridge loaded in slide supply 2 was not correctly identified.
  • Action
    The solution to this anomaly will appear in the next version of software currently under development. We'll issue a follow-up notification as soon as the software is available. In the meantime, if an operator inadvertently accesses a Slide Supply loading port before the green indicator light comes on and the system generates a TAS-70E or TAS-20E condition code (SLIDE SUPPLY 1 is OPEN or the SLIDE PORT SUPPLY 2 is OPEN), the operator must open and close the two Slide Supply ports (Slide Supply No. 1 and 2), remove or load cartridges, and initialize the system. This will cause the system software to scan all slots on the two Slide Supplies to correctly identify the contents.

Device

CHEMICAL SYSTEM VITROS 5,1 FUSION, Registration no. 80145900827, lots: See Annex 1 - Distribution...

Manufacturer

Johnson & Johnson do Brasil Ind. e Com. de Prod. para Saúde Ltda; Ortho-Clinical Diagnostics, Inc.