Events

Alerte De Sécurité sur Trade name: ID-DIAPANEL P Technical name: IMMUNOHEMATOLOGY - ENZYME HEMACY / HEMATELIC REAGENTS Registration number ANVISA: 80004040131 Hazard class: IV Model affected: 004214V Serial numbers affected: 45171.88.1

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 DiaMed Latino América 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
    2195
  • Date
    2017-02-08
  • 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
    * We recommend to immediately stop the use ONLY of test cells 1 of the kit "ID-DiaPanel-P", lot 45171.88.1 and "ID-DiaPanel", lot 45161.88.1. The other test cells (test red cells 2 to 11) are in compliance with the Quality Control criteria and should be used normally. * Identify and segregate boxes of products containing ONLY the test cells 1 of the "ID-DiaPanel-P" kit, lot 45171.88.1 and "ID-DiaPanel", lot 45161.88.1, to be returned to Bio-Rad. * Use the new test cells 1 (ID-DiaPanel-P 1, lot 05361.88.2 and ID-DiaPanel 1, lot 06171.88.2) and the new table of antigens received with the other test cells (2 to 11) of the kit "ID-DiaPanel-P", lot 45171.88.1 and "ID-DiaPanel", lot 45161.88.1.
  • Cause
    It was verified by the bio-rad quality control that the "id-diapanel-p 1" test kit, lot 05361.88.1, component of the kit "id-diapanel-p", lot 45171.88.1, 2017, is presenting results out of specification for polyglutination tests, which may lead to results with "nonspecific" positive reactions with samples from patients and / or donors.
  • Action
    Field Action Code AC 2017/01 triggered under the responsibility of the company DIAMED LATINO AMÉRICA SA Company will make payment.

Device

Trade name: ID-DIAPANEL P Technical name: IMMUNOHEMATOLOGY - ENZYME HEMACY / HEMATELIC REAGENTS R...

Manufacturer

DiaMed Latino América S.A