Slidex Rota-Kit 2 의 안전성 경고

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.

The product is registered in Brazil under the nº 10158120201, valid until 19-12-2006. There are currently no notifications of technical complaints about the product involved in this Alert 829. The Technovigilance Unit is monitoring the actions taken by the company and warns of the importance of customers being aware of the problem and of notifying any technical complaints (technical surveillance @ anvisa.gov.br). The Technovigilance Unit was notified by the company on April 24, 2006. Biomérieux Brasil SA addressed a letter to the clients on 04-07-2006. UPDATE: 06-13-2006: 1.Company sent a letter to the UTVIG (received at Anvisa on 06-07-2006) informing that it has already collected all kits involved in the Alert. 2.The company was directed to seek the State Sanitary Surveillance Center / RJ to carry out the destruction according to the guidelines of the said Center. I look forward to returning information to update the Alert and terminate the notification. UPDATE: 01/22/2007: Company reported that the products were incinerated and that VISA RJ was informed of this procedure on 12/26/2006 by means of correspondence registered in said VISA on 12/27/2006. This notification is now closed.