International safety notice
Alert 2835 (Technosurveillance) Roche Diagnóstica Brasil Ltda.
Brazil / Anvisa · BRA · Mar 28, 2019
Key facts
| Title | Alert 2835 (Technosurveillance) Roche Diagnóstica Brasil Ltda. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Commercial Name: Cobas Pre Analytical Family Technical Name: Instrument for sample preparation and processing pre-analytical phase ANVISA registration number: 10287411162 Risk Class: I Affected model: N/A Affected serial numbers: Cobas Pre Analytical Family Cobas p612 (Code: 07563116001 and Registration: 10287411162): a single impacted serial number = 63025817 |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO ROCHE DIAGNÓSTICA BRASIL LTDA CNPJ 30280358000186 AVENIDA ENGENHEIRO BILLINGS 1729 PRÉDIO 38 SÃO PAULO SP TEL 11 37198464 EMAIL BRASILTECNOVIGILANCIAROCHECOM FABRICANTE DO PRODUTO ROCHE DIAGNOSTICS GMBH SANDHOFER STRASSE 116 68305 ALEMANHA |
| Models | 10287411162, 63025817, 07563116001 |
| Date | Mar 28, 2019 |
| 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