International safety notice
Alert 2966 (Technovigilance) - Abbott Laboratórios do Brasil Ltda - Alinity ci-series Instrument Family Possibility of reusing reaction cells (RVs) after a system stop, which may generate incorrect results.
Brazil / Anvisa · BRA · Aug 22, 2019
Key facts
| Title | Alert 2966 (Technovigilance) - Abbott Laboratórios do Brasil Ltda - Alinity ci-series Instrument Family Possibility of reusing reaction cells (RVs) after a system stop, which may generate incorrect results. |
|---|---|
| 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 Números de série afetados: SCM01737; SCM01311; SCM01623; SCM01646; SCM02076; SCM02082; SCM02083; SCM02373; SCM02283; SCM02327; SCM02208; SCM02370; SCM02186; SCM02652; SCM02682; SCM03098; SCM03099; SCM02187; SCM01509; SCM01510; SCM01559; SCM01637; SCM02303; SCM01730; SCM01656; SCM02679; SCM01729; SCM02188; SCM01659; SCM02372; SCM01636; SCM02309; SCM02317; SCM02151; SCM02677; SCM01662; SCM01663; SCM02651; SCM01307; SCM01139; SCM02516; SCM01246; SCM01535; SCM01644; SCM01731; SCM01314; SCM01536; SCM01539; SCM01540; SCM01542; SCM01545; SCM01548; SCM01557; SCM01242; SCM01243; SCM01253; SCM01254; SCM01349; SCM01350; SCM01467; SCM01482; SCM01487; SCM01488; SCM01489; SCM01490; SCM01498; SCM01752; SCM01753; SCM02173; SCM02177; SCM02179; SCM02374; SCM02292; SCM02318; SCM02369; SCM02366. |
| 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 MAXPLANCKRING 2 65205 WIESBADEN GERMANY ALEMANHA |
| Models | SCM01489, SCM01656, SCM02366, SCM01737, SCM01242, SCM01729, SCM01663, SCM01730, SCM01753, SCM02651, SCM01535, SCM01253 and 65 more |
| Date | Aug 22, 2019 |
| Regulator page | anvisa.gov.br |
At a glance
- No Recall
- No Field safety notice
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