Events

Alerte De Sécurité sur ARCHITECT TESTOSTERONE - Records 80146501466, 80146501467, 80146501468. Affected Lots - 11907JN01, 13909JN01, 15909JN01, 15916JN00, 1897JN01, 18907JN02, 201901JN01, 11907JN00, 13909JN00, 15909JN00, 15916JN01, 18907JN00, 21901JN03, 21901JN04, 17342JN00, 19142JN00, 19142JN01, 19142JN02, 22270JN00 , 23277JN00, 23277JN01, 17203JN00, 19075JN00, 22121JN00 and 23199JN00.

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
    1222
  • Date
    2013-01-15
  • 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
    Exposure to materials containing Methylisothiazolones may cause an allergic skin reaction. Personal protective equipment should be used in accordance with your laboratory practice to ensure adequate protection against such an event. This warning is not a result of any adverse events reported in relation to the product marketed. Anvisa follows this Field Action. #### UPDATE - 04/29/2013 - CLOSURE of the action communicated by the company.
  • Cause
    The current architect testosterone reagents, calibrators and controls labels do not contain warnings and precautions applicable to materials containing methyl-isotiazolones, classified as skin sensitizers.
  • Action
    The company recommends to professionals users: 1) Treat this product as skin sensitizer. 2) If you have forwarded the products listed in the List of Affected Lots list distributed in Brazil to other laboratories, please provide a copy of this notice to the laboratory in question. 3) Keep a copy of this notice for future reference. 4) The instructions for use shall be corrected from the following lots: ARCHITECT Reagents Testosterone, from lot 24900UI01 - Reagents ARCHITECT Testosterone, from lot 24900UI00 - ARCHITECT Testosterone Calibrators, from lot 24912UI00 - Controls ARCHITECT Testosterone, from from lot 24911UI00

Device

ARCHITECT TESTOSTERONE - Records 80146501466, 80146501467, 80146501468. Affected Lots - 11907JN01...

Manufacturer

ABBOTT LABORATÓRIOS DO BRASIL LTDA
  • Source
    ANVSANVISA