International safety notice
Technical name: Urine analysis instrument
Brazil / Anvisa · BRA · Jan 19, 2018
Key facts
| Title | Technical name: Urine analysis instrument |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Trade name: Cobas 6500 - u 601 and u 701 Technical name: Urine analysis instrument ANVISA registration number: 10287411073 Risk class: III Affected model: N/A Affected serial numbers: See attached list on the Anvisa portal - link: http://portal.anvisa.gov.br/informacoes-tecnicas13/-/asset_publisher/WvKKx2fhdjM2/content/alerta-2471-tecnovigilancia-roche-foco-cirurgico- illumina-incompatibility-de-amosa/33868?p_p_auth=PAWpHtof&inheritRedirect=false&redirect=http%3A%2F%2Fportal.anvisa.gov.br%2Finformacoes-tecnicas13%3Fp_p_auth%3DPAWpHtof%26p_p_id%3D101_INSTANCE_WvKKx2fhdj M2%26p_p_lifecycle%3D0%26p_p_state%3Dnormal% 26p_p_mode%3Dview%26p_p_col_id%3Dcolumn-3%26p_p_col_pos%3D1%26p_p_col_count%3D5 |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO ROCHE DIAGNÓSTICA BRASIL LTDA CNPJ 30280358000186 AVENIDA ENGENHEIRO BILLINGS 1729 PRÉDIO 38 SÃO PAULO SP FABRICANTE ROCHE DIAGNOSTICS GMBH SANDHOFER STRASSE 116 68305 EMAIL BRASILTECNOVIGILANCIAROCHECOM |
| Models | 33868?p_p_auth=PAWpHtof&inheritRedirect=false&redirect=http, 26p_p_id, 3Dnormal, 2Fportal.anvisa.gov.br, 3Dview, 3Fp_p_auth, 3DPAWpHtof, 3D101_INSTANCE_WvKKx2fhdjM2, 26p_p_col_count, 26p_p_col_pos, 2Finformacoes-tecnicas13, WvKKx2fhdjM2 and 8 more |
| Date | Jan 19, 2018 |
| 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