International safety notice
Alert 2852 Updated (Technovigilance) - Abbott Laboratórios do Brasil Ltda - Alinity i Processing Module Possibility of temperature errors and eventual failure of the reagent cooler due to loose cable connections.
Brazil / Anvisa · BRA · Apr 18, 2019
Key facts
| Title | Alert 2852 Updated (Technovigilance) - Abbott Laboratórios do Brasil Ltda - Alinity i Processing Module Possibility of temperature errors and eventual failure of the reagent cooler due to loose cable connections. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Nome Comercial: Alinity i Processing Module. Technical Name: Instrument intended for immunoassays. ANVISA registration number: 80146502006. Product type: Diagnostic product for in vitro use. Risk Class: II. Affected model: Alinity i Processing Module. Affected serial numbers: Ai01085; Alert Update: new serial numbers were inserted, corresponding to the updated quantity of products available in Brazil. Access the full content of Alert 2852 with the respective annexes on the ANVISA Portal (http://portal.anvisa.gov.br/alertas). |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO ABBOTT LABORATÓRIOS DO BRASIL LTDA CNPJ 56998701000116 RUA MICHIGAN 735 CIDADE MONÇÕES SÃO PAULO SP TEL 55 11 5536 73126 EMAIL CAMILAFERREIRAABBOTTCOM FABRICANTE DO PRODUTO ABBOTT GMBH CO KG ALEMANHA MAXPLANCKRING 2 65205 WIESBADEN ALEMANHA |
| Models | Ai01785, AI01192, AI01317, AI02844, AI01491, Ai02972, AI02294, Ai01531, AI02778, AI01520, AI02873, AI02760 and 123 more |
| Date | Apr 18, 2019 |
| Regulator page | anvisa.gov.br |
At a glance
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About International device safety notices
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