International safety notice
Alert 2693 (Technovigilance) - Abbott Laboratórios do Brasil Ltda - Alinity S System - Software update required to correct problems that may affect test results.
Brazil / Anvisa · BRA · Oct 9, 2018
Key facts
| Title | Alert 2693 (Technovigilance) - Abbott Laboratórios do Brasil Ltda - Alinity S System - Software update required to correct problems that may affect test results. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Trade Name: Alinity S System Technical Name: Instrument intended for immunoassays ANVISA registration number: 80146502070 Risk Class: II Affected model: Alinity S System Affected serial numbers: AS1060, AS1061 and AS1059 |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO ABBOTT LABORATÓRIOS DO BRASIL LTDA CNPJ 56998701000116 RUA MICHIGAN 735 CIDADE MONÇÕES SÃO PAULO SP TEL 55 11 5536 7356 EMAIL CAMILAFERREIRAABBOTTCOM FABRICANTE DO PRODUTO ABBOTT GMBH CO KG MAXPLANCKRING 2 65205 WIESBADEN ALEMANHA ALEMANHA |
| Models | AS1059, AS1060, AS1061, 80146502070 |
| Date | Oct 9, 2018 |
| 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