Retiro De Equipo (Recall) de Kit de confirm HBs Ag

Según L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en France que fue producido por Ortho-Clinical Diagnostics.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
  • Fecha
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • Notas / Alertas
    French data is current through early September 2018. All of the data comes from L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), 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 recall data from the U.S. and France.
  • Notas adicionales en la data
  • Acción
    On 23/12/2005, Ortho-Clinical Diagnostics withdrew from the market the batch 240 (03/04/2006) and 250 (03/07/2006) of the in vitro diagnostic medical device called Kit de confirm HBs Ag reference 822 8595. This device is used to confirm the presence of hepatitis B virus surface antigen (HBsAg) in human serum and plasma samples (EDTA, heparin or citrate ) found to be repeatable with the Vitros Ag HBs test. This is due to the fact that the sample diluent produces a higher background that may lead to unconfirmed (false negative for HBsAg) results for samples with has given positive results with the Vitros HBs Ag test. This risk concerns only previously diluted samples, that is to say, samples that have obtained a Vitros HBs Ag positive test result> 500 S / C. The company has directly notified the recipients of the offending batches by means of the enclosed message (26/12/2005) (101 KB) validated by Afssaps. The European competent authorities concerned are informed directly by the manufacturer. This information is intended for laboratory managers, health facility directors and reactive vigilance correspondents for dissemination, where appropriate, to the services concerned.