International safety notice
Alert 2832 (Technovigilance) - Abbott Laboratórios do Brasil Ltda - Alinity s System Software update to version V2.5.0 to address known issues and improve the equipment.
Brazil / Anvisa · BRA · Mar 25, 2019
Key facts
| Title | Alert 2832 (Technovigilance) - Abbott Laboratórios do Brasil Ltda - Alinity s System Software update to version V2.5.0 to address known issues and improve the equipment. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Trade Name: Alinity s System Technical Name: Instrument for Immunoassays ANVISA registration number: 80146502070 Risk Class: II Affected model: Alinity s system Affected serial numbers: AS1059, AS1060, AS1061, AS1102. |
| 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 | 80146502070, AS1061, AS1102, AS1060, AS1059 |
| Date | Mar 25, 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