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

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.