Events

Alerte De Sécurité sur ARCHITECT CA 19-9 REAGENTS - Registration 80146501355 - Model ARCHITECT CA19-9XR - Lots Affected: 08849M500, 08851M500, 08852M500, 08853M500, 10122M500, 10040M500.

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 LTDA.

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
    1147
  • Date
    2012-06-28
  • 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
    Abbott confirmed that six batches of the ARCHITECT CA19-9XR reagent show a change in the reported results for patients, and it was found that Abbott controls did not detect this change and presented results within the range. All other batches of reagents are not affected by this change. An internal investigation is under way. Initial indications suggest that the problem is caused by a component of the conjugate. All batches identified below have in common the same component of the conjugate. The investigation and collection of the impacted units in the client are in progress, and the forecast for completion is 09/15/2012. Anvisa follows this action.
  • Cause
    There may be a change in the reported results for patients, without abbott controls detecting this change.
  • Action
    Customers who received batches impacted by this change were notified via an Abbott statement to suspend their use immediately. Abbott will replace the affected products.

Device

ARCHITECT CA 19-9 REAGENTS - Registration 80146501355 - Model ARCHITECT CA19-9XR - Lots Affected:...

Manufacturer

ABBOTT LABORATÓRIOS DO BRASIL LTDA
  • Source
    ANVSANVISA