International safety notice
Alert 2645 (Technovigilance) - Abbott Laboratórios do Brasil Ltda - Alinity ci-series Instrument Family - Potential performance problem in the Alinity ci-series software version 2.10.
Brazil / Anvisa · BRA · Aug 14, 2018
Key facts
| Title | Alert 2645 (Technovigilance) - Abbott Laboratórios do Brasil Ltda - Alinity ci-series Instrument Family - Potential performance problem in the Alinity ci-series software version 2.10. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Trade Name: Alinity ci-series Instrument Family Technical Name: Instrument intended exclusively for joining modules, integrating analyzers or test platforms ANVISA registration number: 80146502000 Risk Class: I Affected model: Alinity ci-series - System Control Module - Processing module Affected serial numbers: Serial number: SCM01311, SCM01139, SCM01307, SCM01248, SCM01246, SCM01247, SCM01249, SCM01314. |
| 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 GERMANY ALEMANHA |
| Models | SCM01311, SCM01247, 80146502000, SCM01246, SCM01314, SCM01139, SCM01248, SCM01249, SCM01307 |
| Date | Aug 14, 2018 |
| Regulator page | anvisa.gov.br |
At a glance
- No Recall
- No Field safety notice
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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