International safety notice
Alert 2686 (Technovigilance) - Roche Diagnóstica Brasil Ltda - Cobas h232 / Accu-Chek Inform II / Coagucheck System / CoaguChek Pro II - Software updates related to cybersecurity.
Brazil / Anvisa · BRA · Sep 27, 2018
Key facts
| Title | Alert 2686 (Technovigilance) - Roche Diagnóstica Brasil Ltda - Cobas h232 / Accu-Chek Inform II / Coagucheck System / CoaguChek Pro II - Software updates related to cybersecurity. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Nome Comercial: Cobas h232 / Accu-Chek Inform II / Sistema Coagucheck / CoaguChek Pro II Technical Name: Hemostasis instrument / Glucose instrument - Point of Care Testing (professional) / Self-test instrument for coagulation parameters / Hemostasis instrument ANVISA registration number: 10287410670 / 10287410863 / 10287410562 / 10287411201 Classe de Risco: II / III / III / II Affected model: N/A Affected serial numbers: See attachment "List of serial numbers" |
| 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 | 10287410562, 10287411201, 10287410863, 10287410670 |
| Date | Sep 27, 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