Events

Safety Alert for SLIDEX STAPH KIT. Anvisa registration number: 10158120557. Affected lots: 10051 and 73113.

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

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
    1025
  • Date
    2010-06-24
  • 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
    According to Biomerieux, the company decided to collect batches 73112 and 73113 from the Slidex Staph Kit as a result of a failure in the product release process: the aforementioned lots were released for commercialization in the national territory before the end of the analyzes carried out in the laboratory. quality control of the company. The Technovigilance Unit is following up on this case. #### The company informed UTVIG on 10/27/2010 about the completion of the field action, with collection of the affected units and the presentation of the certificate of destruction of the same.
  • Reason
    Some batches of the product were marketed without the approval of the company's quality control area.
  • Action
    Users of the product should perform the following actions: (1) Verify in their inventory the presence of affected lots; (2) If a product is identified as being at risk, it must be segregated and the manufacturer informed. The company said it had already sent warning letters to its customers, stating the problem. The product is being collected from the market by Biomerieux.

Device

SLIDEX STAPH KIT. Anvisa registration number: 10158120557. Affected lots: 10051 and 73113.

Manufacturer

BioMerieux Brasil SA.