Events

Alerte De Sécurité sur Commercial Name: ABC-1ML Freeze-dried Rabbit Complement Technical Name: ABC-1ML Lyophilized Rabbit Complement ANVISA Registration Number: 80298490007 Hazard Class: III Affected Model: CABC-1D Serial Numbers Affected: • 031-0000100559

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
    2146
  • Date
    2017-02-10
  • 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 properly. product use: the rabbit complement is intended for use in conjunction with other reagents for the determination of hla class i antigens on the cell surface by the complement-dependent microlymphocytotoxicity (cross-exam) test. the objective of the cross-over test is to verify if the patient who needs to receive an organ transplant presents anti-hla antibodies against the possible donor. how is the test: viable lymphocytes from the prospective donor are incubated with patient serum samples. if the lymphocyte has an antigen recognized by an anti-hla antibody, the fab portion of the antibody binds to the antigen, forming an antigen-antibody complex. the rabbit complement is then added to the reaction, and if antibody antigen complexes are formed, the c1q fraction and ca ++ of the complement bind to the fc portion of the antibody. this binding initiates the cascade of the complement system, which induces lysis of the cell in which the antigen-antibody complex is present. thus, in a negative reaction, the lymphocytes remain viable, and this is a favorable situation for the continuity of the transplantation process. in a positive reaction, the cell death of the lymphocytes occurs, contraindicating the transplantation between this patient and this donor. we were notified by the supplier that the rabbit complement could be discolored and could not be active and not cause death of the lymphocytes and as a result there would be no reactions. 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 OC1670 triggered under the responsibility of the company BIOMETRIX DIAGNÓSTICA LTDA. Company will collect.

Device

Commercial Name: ABC-1ML Freeze-dried Rabbit Complement Technical Name: ABC-1ML Lyophilized Rabbi...

Manufacturer

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