International safety notice
Technical name: Streptococcus
Brazil / Anvisa · BRA · Dec 20, 2017
Key facts
| Title | Technical name: Streptococcus |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Trade name: Xpert GBS Technical name: Streptococcus ANVISA registration number: 81062710019 Risk class: III Affected model: Kit with 10 tests (cartridges with integrated reaction tubes). Affected serial numbers: 1. 1000038939; |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO CEPHEID BRASIL IMPORTAÇÃO EXPORTAÇÃO E COMÉRCIO DE PRODUTOS DE DIAGNÓSTICOS LTDA CNPJ 18628083000123 RUA LUIGI GALVANI Nº 200 CONJUNTO 51 5º ANDAR CIDADE MONÇÕES CEP 04575020 SÃO PAULO SP FABRICANTE CEPHEID 904 CARIBBEAN DRIVE SUNNYVALE CA 94089 ESTADOS UNIDOS TELEFONE 1 40 8541 4191 |
| Models | 1000064922, 1000050712, 1000054880, 81062710019, 1000038939, 1000047891 |
| Date | Dec 20, 2017 |
| Regulator page | anvisa.gov.br |
At a glance
- No Recall
- No Field safety notice
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About International device safety notices
Field safety notices, recalls and safety alerts published by about 30 national medical device regulators outside the United States, matched by Orca1 to FDA device data.
Source: National medical device regulators (as listed), compiled by Orca1