International safety notice
Technical name: Biochemical Analyzer/ Biochemical Analyzer
Brazil / Anvisa · BRA · Oct 18, 2016
Key facts
| Title | Technical name: Biochemical Analyzer/ Biochemical Analyzer |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Commercial name: SISTEMA QUÍMICO VITROS 4600/ SYSTEM INTEGRATED VITROS 5600 Technical name: Biochemical Analyzer/ Biochemical Analyzer ANVISA registration number: 80145901335 Risk class: I Affected model: S.Químico Vitros 4600(R.Anvisa 80145901335)/S.Integrado Vitros 5600(R.Anvisa 80145901205) Affected serial numbers: VITROS® 4600 Chemistry System, Software Version 3.3, Product Code 6802445. VITROS® 5600 Integrated System, Software Version 3.3, Product Code 6802413 and 6802915. |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO JOHNSON JOHNSON DO BRASIL IND E COM DE PROD PARA SAÚDE LTDA CNPJ 54516661000101 LOCALIZADA NA AV JUSCELINO KUBITSCHEK Nº 2041 ANDARES 8º E 9º COMPLEXO JK BLOCO B SÃO PAULO SP FABRICANTE ORTHOCLINICAL DIAGNOSTICS INC LOCALIZADA EM 100 INDIGO CREEK DRIVE ROCHESTER NEW YORK 146265101 EUA |
| Models | 80145901335, 6802915, 6802445, 80145901205, 6802413 |
| Date | Oct 18, 2016 |
| 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