Events

Alerte De Sécurité sur SIMPLASTIN EXCEL - Lots: 161550, 161551, 161583, 161585, 161595, 161657, 161658, 161552, 161586, and 161596.

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 Biomérieux 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
    703
  • Date
    2003-04-07
  • 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 any, please contact BIOMÉRIEUX BRASIL S / A, by telephone 21 2444.1483 - Technical Assistance to Reagents, 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. According to the company's statement, the termination of this payment is scheduled until August 26, 2003.
  • Cause
    Prolonged results in coagulation times. there is variation of the measured levels of vacuum remaining in the lyophilized vials. this vacuum failure was identified as the cause of the randomly altered clotting times in those batches. according to this information, the presence of atmospheric air together with an active principle would be the cause of the poor performance observed in certain batches.
  • Action
    The company informs that a number of Corrective Actions have been implemented for both the Simplastin Excel S product lines and Simplastin Excel. These are: Vacuum control, bottle to bottle, more stringent, improvement of the bottle closure system in the production process and revision of the technical procedure sheets: In the instructions for use a check of the reconstitution of the freeze-dried tablets by the customer, as well as performing a double quality control test before using the vial for testing. Collection of products manufactured in the period from February 2000 to November 2002.

Device

SIMPLASTIN EXCEL - Lots: 161550, 161551, 161583, 161585, 161595, 161657, 161658, 161552, 161586, ...

Manufacturer

Biomérieux Brasil S.A
  • Source
    ANVSANVISA