International safety notice
VITROS 4600 CHEMICAL SYSTEM / VITROS 5.1 FUSION CHEMICAL SYSTEM
Brazil / Anvisa · BRA · Dec 18, 2015
Key facts
| Title | VITROS 4600 CHEMICAL SYSTEM / VITROS 5.1 FUSION CHEMICAL SYSTEM |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | VITROS 4600 CHEMICAL SYSTEM (Reg 80145900827) / VITROS 5.1 FUSION CHEMICAL SYSTEM (Reg 80145900827) Risk class: I Affected Products: All VITROS® 4600 Diagnostic Systems with software version 3.2 and earlier and all VITROS® 5.1 Fusion Diagnostic Systems with software version 2.8 and earlier. |
| Manufacturer | DETENTOR DO REGISTROJOHNSON JOHNSON DO BRASIL IND E COM DE PROD PARA SAÚDE LTDA CNPJ 54516661000101 ENDEREÇO RUA GERIVATIBA 207 SÃO PAULOSP TELEFONE DE CONTATO GISELE BUOSI 55 12 39327977 FABRICANTE ORTHO CLINICAL DIAGNOSTICS INC ENDEREÇO 100 INDIGO CREEK DRIVE NEW YORK EUA |
| Models | 80145900827 |
| Date | Dec 18, 2015 |
| 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