Events

Alerte De Sécurité sur CORTISOL, LIAISON CORTISOL, record 10339840213, affected lot numbers: 244511X; 244521X; Risk class II

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 DiaSorin Ltda.; DiaSorin S.p.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
    1709
  • Date
    2015-10-02
  • 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
    According to the registry holder, if the values ​​of the controls are outside the new ranges informed, the results need to be reviewed and informed to the clinician and according to the instructions for use of the product, patient results can only be interpreted in the answer to the table clinical and other diagnostic procedures.
  • Cause
    When the following bio-rad controls are used: lyphocheck immunoassay control, lot # 40310; liquicheck urine chemistry control, lot # 66700; lyphocheck quantitative urine control, lot no. 63350; in conjunction with the liaison cortisol kits for lots 244511x and 244521x, the values ​​and the theoretical ranges reported in the bio-rad leaflet are not appropriate. in these cases, the values ​​of the controls need to be changed in accordance with the attached technical note.
  • Action
    Change control ranges if using the BIO-RAD controls of batches reported above. According to the company, the results already released need to be revised according to the results of the controls, if they were with the values ​​within the new ranges informed, no action is necessary if the results of the controls are with the results outside the new ranges the routine needs to be considered invalid by reviewing the sample values. Action code: FSN-29092015-1.

Device

CORTISOL, LIAISON CORTISOL, record 10339840213, affected lot numbers: 244511X; 244521X; Risk clas...

Manufacturer

DiaSorin Ltda.; DiaSorin S.p.A.