Events

Alerte De Sécurité sur Fibriquik - Lot: 111169 and Fibriquik Thrombin Reagent - Lots: 113049, 113050

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 BIOMERIEUX BRASIL S/A.

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
    781
  • Date
    2004-08-31
  • 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 your stock, if you have stocked kits, collect and return immediately to the company, correctly filling out the return certificate sent by the company. For more information, contact BIOMERIEUX BRASIL S / A by telephone at (0xx21) 2444.1400 . The UTVIG - Technovigilance Unit will be following the whole process (recall) until the moment of its closure.
  • Cause
    High and unexpected values ​​of controls using fibriquik.
  • Action
    The company informs that it has received some customer reports regarding the high and unexpected values ​​of the controls using Fibriquik. These reports were confirmed during the internal investigations. It was found that the altered values ​​are due to low levels of thrombin activity in the flask, causing prolonged coagulation times and some imprecision. However, internal research has shown that this does not compromise patient outcomes. Detailed internal studies were performed to demonstrate that international standards, label values, and plasma levels of patients recovered from standard curves using Fibriquik that have less activity than standard thrombin are comparable to those obtained with Fibriquik that has normal levels of thrombin activity . Since we identified products with lower than normal levels of thrombin activity, which could cause undesirable imprecision, we request that the use of the aforementioned Fibriquik batches be suspended.

Device

Fibriquik - Lot: 111169 and Fibriquik Thrombin Reagent - Lots: 113049, 113050

Manufacturer

BIOMERIEUX BRASIL S/A
  • Source
    ANVSANVISA