International safety notice
Alert 2860 (Technovigilance) Update Biomérieux Brasil Indústria e Comércio de Produtos Laboratoriais Ltda.
Brazil / Anvisa · BRA · Apr 29, 2019
Key facts
| Title | Alert 2860 (Technovigilance) Update Biomérieux Brasil Indústria e Comércio de Produtos Laboratoriais Ltda. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Nome Comercial: FilmArray GI Panel (10158120696), FilmArray 2.0 (10158120704), FilmArray Torch (10158120712) Technical Name: FilmArray Gastro Intestinal GI Panel (10158120696), Nucleic acid analysis instrument (10158120704, 10158120712) ANVISA registration number: 10158120696, 10158120704, 10158120712 Risk Class: Class III Affected model: Not applicable Affected serial numbers of FilmArray Gastro Intestinal GI Panel Ref. RFIT-ASY-0116 - Lot: 0423418 (07 units imported). Números de série afetados do Filmarray 2.0: 2FA05782/2FA05840; 2FA05852/2FA05834; 2FA05772; 2FA06491; 2FA06281; 2FA06490/2FA06450; 2FA05794; 2FA05967; 2FA06288; 2FA05798; 2FA06250; 2FA06516; 2FA05768; 2FA05800; 2FA05202; 2FA05874; 2FA05824; 2FA06665/2FA06660; 2FA05779/2FA05778/2FA05774/2FA05747; 2FA06507. Affected Torch serial numbers: Company stated that the product was not sold. |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO BIOMÉRIEUX BRASIL INDÚSTRIA E COMÉRCIO DE PRODUTOS LABORATORIAIS LTDA CNPJ 33040635000171 ESTR MAPUÁ 491 LOTE 1 TAQUARA JACAREPAGUA RIO DE JANEIRO RJ TEL 21 2444 1437 EMAIL NUBIAOLIVEIRABIOMERIEUXCOM FABRICANTE DO PRODUTO BIOFIRE DIAGNOSTIC LLC BIOFIRE DIAGNOSTICS LLC 515 COLOROW DRIVE SALT LAKE CITY UTAH 84108 ESTADOS UNIDOS DA AMÉRICA |
| Models | 2FA05779, 2FA06250, 2FA05774, RFIT-ASY-0104, 2FA05874, 2FA06660, 2FA05800, 10158120696, RFIT-ASY-0116, 2FA05794, 2FA05202, 2FA06491 and 22 more |
| Date | Apr 29, 2019 |
| 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