International safety notice
Technical name: PROSTATIC SPECIFIC ANTIGEN (PSA)
Brazil / Anvisa · BRA · Jan 12, 2017
Key facts
| Title | Technical name: PROSTATIC SPECIFIC ANTIGEN (PSA) |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Commercial name: PSA Third Generation IMMULITE/ IMMULITE 1000 Technical name: PROSTATIC SPECIFIC ANTIGEN (PSA) ANVISA registration number: 10345160987 Risk class: III Affected model: Kit 100 tests / Kit for 500 tests Affected serial numbers: 336; |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO SIEMENS HEALTHCARE DIAGNÓSTICOS SA CNPJ 01449930000190 ENDEREÇO AV MUTINGA 3800 7º ANDAR PIRITUBA SÃO PAULOSP TELEFONE 0800 129 633 FABRICANTE SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD GLYN RHONWN LLANBERIS GWYNEDD LL55 4EL REINO UNIDO |
| Models | 10345160987 |
| Date | Jan 12, 2017 |
| 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