Events

Safety Alert for 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

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
    2322
  • Date
    2017-06-27
  • 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 (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