Events

Alerte De Sécurité sur Vitros Chemistry Systems: (1) Model 950, (2) Model 950AT. Series Nos .: (1) below 09501559, (2) below 09600129

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 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
    223
  • Date
    2000-12-15
  • 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
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • Cause
    In the chemical systems described, an atypical pattern occurred in the relation between the millivolt slide used to calculate a predicted concentration and the reading of the millivolt slide used to evaluate the slide impedance. the manufacturer initiated a correction by mail dated february 28, 2000.
  • Action
    Make sure you have received the correspondence sent on February 28, 2000, by Ortho-Clinical Diagnostics. Confirm that software version 2.04 or newer is installed on the systems described. Ortho-Clinical Diagnostics states that removal in the United States is now complete. No additional action is required by US service providers. International removal is in progress. Contact your local Ortho-Clinical Diagnostics representative or directly to the United States by mail at the address listed for more information on removal procedures.

Device

Vitros Chemistry Systems: (1) Model 950, (2) Model 950AT. Series Nos .: (1) below 09501559, (2) b...

Manufacturer

Ortho-Clinical Diagnostics Inc