International safety notice
Alert 2688 (Technovigilance) - Roche Diagnóstica Brasil Ltda - Elecsys Analyzer - Modification of the pinch valve tubing replacement interval for the cobas e 411 analyzer.
Brazil / Anvisa · BRA · Oct 2, 2018
Key facts
| Title | Alert 2688 (Technovigilance) - Roche Diagnóstica Brasil Ltda - Elecsys Analyzer - Modification of the pinch valve tubing replacement interval for the cobas e 411 analyzer. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Trade Name: Elecsys Analyzer Technical Name: Instrument for analysis of general biochemistry, hormones, drugs or proteins ANVISA registration number: 10287410608 Risk Class: II Affected model: COBAS e411 Affected serial numbers: See attachment "List of serial numbers at risk" |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO ROCHE DIAGNÓSTICA BRASIL LTDA CNPJ 30280358000186 AVENIDA ENGENHEIRO BILLINGS 1729 PRÉDIO 38 SÃO PAULO SP TEL 11 37198464 EMAIL PAULABRESCIANIROCHECOM FABRICANTE DO PRODUTO ROCHE DIAGNOSTICS GMBH SANDHOFER STRASSE 116 68305 ALEMANHA |
| Models | 10287410608 |
| Date | Oct 2, 2018 |
| 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