Events

Alerte De Sécurité sur ALCYON HDL, ANVISA Registration No. 10055310869, LIST 8D42-02, LOTES 85124HW00, 89031HW00 and 92010HW00

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
    744
  • Date
    2003-06-06
  • 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
    Check if there are any batches in your stock. If you do, please contact ABBOTT LABORATORIOS DO BRASIL LTDA, by calling 0800-119099 or your local representative, in order to make the return and consequently the replacement of the same. The UTVIG - Technovigilance Unit is monitoring the entire collection, return and replacement process until it closes.
  • Cause
    They may deteriorate before the expiration date. the degradation of the reagent is indicated by the inability to produce acceptable calibrations and / or to recover controls within acceptable limits. in addition, linearity samples in the linearity range of the 180 mg / dl assay may not meet acceptable criteria. if calibrations and controls are within limits, patient outcomes were not affected for the batch numbers mentioned.
  • Action
    Identify whether you are currently using or own stock of the ALCYON HDL Direct Reagent, lots 85124HW00,89031HW00 and 92010HW00 discontinue and store in your lab for later return.

Device

ALCYON HDL, ANVISA Registration No. 10055310869, LIST 8D42-02, LOTES 85124HW00, 89031HW00 and 920...

Manufacturer

ABBOTT LABORATÓRIOS DO BRASIL LTDA
  • Source
    ANVSANVISA