Events

Safety Alert for 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

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by BIOMETRIX DIAGNOSTICA LTDA; One Lambda, Inc..

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    2146
  • Date
    2017-02-10
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    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.
  • Extra notes in the data
    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.
  • Reason
    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