International safety notice
Alert 2625 (Technovigilance) - Biomérieux Brasil Indústria e Comércio de Produtos Laboratoriais Ltda.
Brazil / Anvisa · BRA · Jul 24, 2018
Key facts
| Title | Alert 2625 (Technovigilance) - Biomérieux Brasil Indústria e Comércio de Produtos Laboratoriais Ltda. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Trade Name: FilmArray BCID Panel Technical Name: Parameters combined in the same product ANVISA registration number: 10158120695 Risk Class: III Affected model: N/A Affected serial numbers: 545518 / 597818 / 612418 |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO BIOMÉRIEUX BRASIL INDÚSTRIA E COMÉRCIO DE PRODUTOS LABORATORIAIS LTDA CNPJ 33040635000171 ESTRADA DO MAPUÁ 491 LOTE 1 TAQUARA JACAREPAGUÁ RJ RJ TEL 21 24441415 EMAIL SUELENSILVABIOMÉRIEUXCOM FABRICANTE DO PRODUTO BIOFIRE DIAGNOSTICS LLC 515 COLOROW DRIVE SALT LAKE CITY UTAH 84108 EUA EUA |
| Models | 545518, 10158120695, 612418, 597818 |
| Date | Jul 24, 2018 |
| Regulator page | anvisa.gov.br |
At a glance
- No Recall
- No Field safety notice
- 1–9 Matching device models in FDA data
- 1–9 Matching catalog numbers in FDA data
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