International safety notice
Technical name: Physiological Fluid Analyzer
Brazil / Anvisa · BRA · Aug 18, 2017
Key facts
| Title | Technical name: Physiological Fluid Analyzer |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Trade name: Cobas 8000 Core Unit Technical name: Physiological Fluid Analyzer ANVISA registration number: 10287410878 Risk class: II Affected model: N/A Affected serial numbers: 1137-08; 15K4-08; 15K5-01; 15M4-01; 15M4-02; 15P0-01; 15P6-01; 15R9-07; 15R9-08; 15R9-10; 15S1-01; 15S3-02; 1618-07; 1618-08; 1628-02; 1640-06; 1653-03; 1656-06; 1657-02; 1657-03; 16S9-06; 16S9-07; 16U5-06; 16U5-07; 16U7-04; 16V8-04; 16V8-05; 16V8-06; 16V8-08; 16W0-10; 16X1-02; 16X1-03; 16X1-04; 16X1-05; 16Y7-01; 16Y7-02; 16Y7-03; 16Z1-09; 16Z7-08; 1776-05; 1776-07 |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO ROCHE DIAGNÓSTICA BRASIL LTDA CNPJ 30280358000186 AVENIDA ENGENHEIRO BILLINGS 1729 PRÉDIO 38 SÃO PAULO SP FABRICANTE ROCHE DIAGNOSTICS GMBH SANDHOFER STRASSE 116 68305 ALEMANHA EMAIL BRASILTECNOVIGILANCIAROCHECOM |
| Models | 1296-09, 16V8-05, 1480-10, 15H3-03, 16U5-07, 14F1-13, 1163-02, 16S9-07, 1485-06, 1657-02, 16Z7-08, 15S1-01 and 79 more |
| Date | Aug 18, 2017 |
| 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