International safety notice
Alert 2673 (Technosurveillance) - Cepheid Brasil Imp, Exp e Comércio de Produtos de Diagnósticos Ltda.
Brazil / Anvisa · BRA · Sep 14, 2018
Key facts
| Title | Alert 2673 (Technosurveillance) - Cepheid Brasil Imp, Exp e Comércio de Produtos de Diagnósticos Ltda. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Trade Name: Xpert HIV-1 Viral Load Technical Name: Human Immunodeficiency Virus Type 1 (HIV 1) nucleic acid ANVISA registration number: 81062710014 Risk Class: IV Affected model: kit containing 10 tests (cartridges with integrated reaction tubes) Affected serial numbers: 1000042897; |
| 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 TEL 11 35248362 EMAIL FERNANDAAZEVEDODEALMEIDACEPHEIDCOM FABRICANTE DO PRODUTO CEPHEID AB RÖNTGENVÄGEN 5 SE171 54 SOLNA SUÉCIA |
| Models | 1000079402, 1000067446, 1000066410, 1000044167, 1000056582, HIV-1, 1000052949, 1000072817, 1000042897, 81062710014 |
| Date | Sep 14, 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