International safety notice
Alert 2589 (Technosurveillance) - Roche Diabetes Care Brasil Ltda.
Brazil / Anvisa · BRA · Jun 15, 2018
Key facts
| Title | Alert 2589 (Technosurveillance) - Roche Diabetes Care Brasil Ltda. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Commercial Name: Accu-Chek Performa Technical Name: Glucose Self-Test ANVISA registration number: 81414021687 Risk Class: III Affected model: Accu-Chek Performa (50 strips) Affected serial numbers: Single batch affected for Brazil: 476586 |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO ROCHE DIABETES CARE BRASIL LTDA CNPJ 23552212000187 AVENIDA ENGENHEIRO BILLINGS 1729 PRÉDIO 38TÉRREO SÃO PAULO SP TEL 11 37198305 EMAIL CAROLINEGASPARROCHECOM FABRICANTE DO PRODUTO ROCHE DIABETES CARE GMBH SANDHOFER STRASSE 116 68305 ALEMANHA |
| Models | 476586, 81414021687 |
| Date | Jun 15, 2018 |
| Regulator page | anvisa.gov.br |
At a glance
- No Recall
- No Field safety notice
- 10–99 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