Events

Alerta De Seguridad para Commercial Name: ABC - 1ML LYOPHILIZED BUNNY COMPLEMENT Technical Name: ABC - 1ML LYOPHILIZED BUNNY COMPLEX Anvisa Record Number: 80298490007 Hazard Class: III Affected Model: CABC - 1D Serial Numbers Affected: 031-68881

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por One Lambda, Inc..

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • ID del evento
    2062
  • Fecha
    2017-01-30
  • País del evento
    Brazil
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (AE) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System. To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link
  • Causa
    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.
  • Acción
    Field Action Code OC1670 triggered under the responsibility of the company BIOMETRIX DIAGNOSTICA LTDA. Company will notify customer and verify results.

Device

Commercial Name: ABC - 1ML LYOPHILIZED BUNNY COMPLEMENT Technical Name: ABC - 1ML LYOPHILIZED BUN...

Manufacturer

One Lambda, Inc.