International safety notice
Alert 2856 (Technosurveillance) Roche Diagnóstica Brasil Ltda cobas e 801 module Possibility of signal drop in cobas e 801 after changing the ProCell II M bottle.
Brazil / Anvisa · BRA · Apr 24, 2019
Key facts
| Title | Alert 2856 (Technosurveillance) Roche Diagnóstica Brasil Ltda cobas e 801 module Possibility of signal drop in cobas e 801 after changing the ProCell II M bottle. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Commercial Name: Module cobas e 801 Technical Name: Instrument intended for immunoassays ANVISA registration number: 10287411196 Risk Class: II Affected model: N/A 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 BRASILTECNOVIGILANCIAROCHECOM FABRICANTE DO PRODUTO ROCHE DIAGNOSTICS GMBH SANDHOFER STRASSE 116 68305 ALEMANHA |
| Models | 10287411196 |
| Date | Apr 24, 2019 |
| 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