Events

Alerte De Sécurité sur Technical Name: TOXOPLASMA GONDII Registration Number ANVISA: 80146501651 Hazard Class: III Affected Model: Not applicable Serial Numbers Affected: 64245LI00; 66063LI00; 67003LI00; 68443LI00; 69252LI00; 70171LI00; 66066LI00; 67006LI00; 68444LI00; 69253LI00 and 70174LI00.

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 Abbott Laboratórios do Brasil; Inpeco S.A..

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
    2162
  • Date
    2016-12-13
  • 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
    Review this release with your Medical Director. Additional tests with a secondary method are recommended to confirm the reactive results (= 0.60 Index or = 1.00 S / CO) for samples from immunocompromised or newborn infants or umbilical cord blood samples and other samples with expected low concentrations of IgM . Keep this notice in your lab files
  • Cause
    For the architect toxo igm assay, an increase in false gray and / or reactive zone results was observed for samples from immunocompromised or newborn patients, as well as umbilical cord blood samples with batches indicated above. these types of samples have a low total igm titer in common. internal studies with the architect toxo igm assay have demonstrated that samples from pregnant women and serum and plasma samples from blood donors are not impacted and meet the specificity specifications of the assay. abbott has identified a solution to the problem and plans a product modification for the first quarter of 2017.
  • Action
    Field Action Code FA14NOV2016 triggered under the responsibility of ABBOTT LABORATORIES DO BRASIL LTDA. Company will make correction in the field.

Device

Technical Name: TOXOPLASMA GONDII Registration Number ANVISA: 80146501651 Hazard Class: III Affec...

Manufacturer

Abbott Laboratórios do Brasil; Inpeco S.A.
  • Source
    ANVSANVISA