Events

Alerte De Sécurité sur Calibrators T4 Total Architect. Schedule 6C49-01; Lots # 71756Q100

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 Laboratories Health Products.

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
    468
  • Date
    2002-01-16
  • 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
    Informs that the Brazil unit of Abbott Laboratories received only 2 (two) Product Kits ARCHITECT T4 total Calibrator, Listing # 6C49-01; Lots # 71756Q100, and that none of the units have been sold, and are hitherto segregated in stock awaiting destruction, until an adequate volume of products has been accumulated to justify the incineration process.
  • Cause
    Calibrators when used to calibrate the t4 total architect assay show a trend of decreasing 9% in patient outcomes. the abbott total t4 lower controls and medium (m) controls also have the potential to identify lower label specifications (66-9229 / r1). the distributor started removal by letter dated august 20, 2001.
  • Action
    Make sure you have received Abbott's letter dated August 20, 2001. Identify and isolate any affected product in your inventory. Destroy all material with the lot number above that you have in your laboratory or stocked at the facility according to laboratory procedures. If you have sent any affected product to another laboratory, please provide the lab, copy the Abbott letter. For more information, contact your local representative. ANVISA has provided the Forms of Notifications of Occurrences on the Internet www.anvisa.gov.br/tecnovigilancia to notify you if you encounter any problems with the products in your inventory

Device

Calibrators T4 Total Architect. Schedule 6C49-01; Lots # 71756Q100

Manufacturer

Abbott Laboratories Health Products
  • Source
    ANVSANVISA