Events

Safety Alert for LIVES HBsAg ULTRA. Registered N °: 10158120583. Lot Affected: 820592901.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Biomerieux Brasil S.A..

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
    937
  • Date
    2008-08-02
  • 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
    Inside the kit are two silver packs containing the cones. In this case, some of the VIDAS HBsAg Ultra product packs were filled with VIDA CK-MB kit cones and labeled as VIDAS HBsAg Ultra.
  • Reason
    Some product units belonging to lot 820592901 were filled with material from a different diagnostic kit (vidas ck-mb) and labeled as vidas hbsag ultra.
  • Action
    Biomérieux Brasil SA has already started, through communication letters, the contact with the clients involved. The collection of affected products in Brazil has also been started by the company. The recommendations to the users are as follows: (1) for all the tests carried out with the product (of the lot under risk) and that presented NEGATIVE result, to contact the patients and to arrange a new test; (2) Immediately verify in stock the existence of lot no. 820592901 of the product; (3) If products of the batch in stock are located, segregate the products at risk and identify them immediately in order to avoid their use; (4) Contact the company through the Product Pickup Notification Letter; (5) Confirm, prior to the laboratory analysis and regardless of the batch number, whether the color of the BARRETE is the same as that of the CONE.

Device

LIVES HBsAg ULTRA. Registered N °: 10158120583. Lot Affected: 820592901.

Manufacturer

Biomerieux Brasil S.A.