International safety notice
Alert 2538 (Technosurveillance) Roche - Cobas e801 Module Problem with the device's syringe plunger.
Brazil / Anvisa · BRA · Apr 6, 2018
Key facts
| Title | Alert 2538 (Technosurveillance) Roche - Cobas e801 Module Problem with the device's syringe plunger. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Trade name: Cobas e801 Module Technical name: Instrument intended for immunoassays ANVISA registration number: 10287411196 Risk class: II Affected Model:- Affected Lot/Series Numbers: 1741-08 (Roche), 1765-02, 1766-04, 1766-05, 1768-07, 1768-08, 1768-09, 1767-08, 1768-10, 1767-07, 1772-04, 1771-03 |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO ROCHE DIAGNÓSTICA BRASIL LTDA CNPJ 30280358000186 AVENIDA ENGENHEIRO BILLINGS 1729 PRÉDIO 38 SÃO PAULO SP TEL 11 37198464 PAULABRESCIANIROCHECOM FABRICANTE ROCHE DIAGNOSTICS GMBH SANDHOFER STRASSE 116 68305 ALEMANHA |
| Models | 1799-05, 1766-04, 1765-02, 1791-07, 18E0-05, 1767-08, 1796-10, 1787-10, 1791-06, 1772-04, 1771-06, 1741-08 and 13 more |
| Date | Apr 6, 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