International safety notice
Alert 2734 (Technovigilance) - Biomérieux - Vikia HBsAg - Labeling error in specific batches.
Brazil / Anvisa · BRA · Nov 19, 2018
Key facts
| Title | Alert 2734 (Technovigilance) - Biomérieux - Vikia HBsAg - Labeling error in specific batches. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Commercial Name: Wikia HBsAg Technical Name: Vikia HBsAg ANVISA registration number: 10158120579 Risk Class: Class IV Affected model: Ref.: 418008 (Presentation with 25 Vikia HBsAg kits + 25 lancets + 25 microtubes) Affected serial numbers: 1005799740; |
| 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 SA FRANÇA CHEMIN DE LORME 69280 MARCY LÉTOILE 21 24441415 FRANÇA |
| Models | 1005854960, 10158120579, 418008, 1005799740, 1005846790 |
| Date | Nov 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