Events

Alerte De Sécurité sur AxSYM CA15-3 MASTER Calibrator no. List 3B42-30, Lot no. 86504M300. CA15-3 STANDARD Calibrator no. List 9C08-01, Lot no. 88127M100, Reg. Anvisa no. 10055311039

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
    712
  • Date
    2003-03-28
  • 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
    The company informs: That it is conducting research to determine the cause. The supply is standardized as other batches of CA 15-3 gauges were unaffected and available in stock. Any questions please contact the Customer Service Center (0800-119099).
  • Cause
    Abbott laboratories - dignity division has identified that calibrators ca 15-3 (axsym ca15-3 master calibrator no. list 3b42-30, lot no. 86504m300 ca15-3 standard calibrator no. list 9c08-01, lot no. 88127m100) may cause a decrease of values ​​for the ca15-3 high control and for patient samples. these lower values ​​can have the following effects: - there is possibility of obtaining lower or out of control values ​​of the instructions for use, causing an invalid test.- patient results can be decreased by about 6.5 - 7.4 %. this small change should not affect patient management.
  • Action
    -Identify if there is in your stock the said product. - Discontinue use of these. -Preply the response protocol, for later return and bonus of the product. -Recall the CA 15-3 test using a different calibrator batch. -You may need to re-establish control strips when using a new batch of calibrators.

Device

AxSYM CA15-3 MASTER Calibrator no. List 3B42-30, Lot no. 86504M300. CA15-3 STANDARD Calibrator no...

Manufacturer

Abbott Laboratórios do Brasil Ltda
  • Source
    ANVSANVISA