International safety notice
Alert 2719 (Technosurveillance) - Biomérieux - Vitek2 AST Cards - ST 03 - Possibility of false-resistant ceftriaxone results for Streptococcus anginosus, Streptococcus constellatus and Streptococcus intermedius.
Brazil / Anvisa · BRA · Nov 1, 2018
Key facts
| Title | Alert 2719 (Technosurveillance) - Biomérieux - Vitek2 AST Cards - ST 03 - Possibility of false-resistant ceftriaxone results for Streptococcus anginosus, Streptococcus constellatus and Streptococcus intermedius. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Commercial Name: VITEK2 AST FAMILY - BIOMERIEUX Technical Name: Device for Identification and Antibiogram of microorganisms ANVISA registration number: 10158120592 Risk Class: Class II Affected model: Vitek AST - ST 03 Affected serial numbers: All Vitek2 AST - ST 03 cards (ref. 421040) |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO BIOMÉRIEUX BRASIL INDÚSTRIA E COMÉRCIO DE PRODUTOS LABORATORIAIS LTDA CNPJ 33040635000171 ESTRADA DO MAPUÁ 491 LOTE 1 TAQUARA JACAREPAGUÁ RIO DE JANEIRO RJ TEL 21 24441415 EMAIL SUELENSILVABIOMERIEUXCOM FABRICANTE DO PRODUTO BIOMÉRIEUX INC 595 ANGLUM ROAD HAZEWOOD MO 63042 ESTADOS UNIDOS DAS AMÉRICAS |
| Models | VITEK2, 421040, Vitek2, 10158120592 |
| Date | Nov 1, 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