Events

Alerte De Sécurité sur Product Name: ABC-1ML Freeze-dried Rabbit Complement Technical Name: ABC-1ML Freeze-dried Rabbit Complement ANVISA Registration Number: 80298490007 Hazard Class: III Model Affected: CABC-1D Serial Numbers Affected: 031-0000151994; 031-0000162312

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 BIOMETRIX DIAGNOSTICA LTDA; One Lambda, Inc..

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
    2322
  • Date
    2017-06-27
  • 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
    Review the results generated with the above product. Test results impacted by this batch should be analyzed by the laboratory manager. Further analysis may be required to confirm the test results. If there are products in stock, they should be discarded and replaced by the supplier.
  • Cause
    The product may be discolored and not working (without activity), causing no results to be obtained. it is possible to identify the problem from the performance of the positive control that in the reaction will be negative, that is, the functionality of the reagent is easily identifiable by the control used in the reaction.
  • Action
    Field Action Code OC226 triggered under the responsibility of the company Biometrix Diagnostica LTDA. Company will notify customer and verify results.

Device

Product Name: ABC-1ML Freeze-dried Rabbit Complement Technical Name: ABC-1ML Freeze-dried Rabbit ...

Manufacturer

BIOMETRIX DIAGNOSTICA LTDA; One Lambda, Inc.
  • Source
    ANVSANVISA