Abbott recalls Alinity ci series System Control Module (v2.6.0/v2.6.1) due to potential incorrect test results after system stops. Affected units may need software update to prevent errors.
Abbott has identified an issue with all on market versions (v2.6.0 and v2.6.1) of Alinity ci series Software where incorrect results may occur after a system Stop due to the Alinity i re use of reaction vessels (RVs). This issue only occurs if the system is transitioned from Processing to Stopped to Idle.
Abbott is recalling Alinity ci series System Control Modules with software versions 2.6.0 and 2.6.1. These versions may produce incorrect test results if the system stops and then restarts. This could affect lab test accuracy.
The software issue occurs when the system transitions from Processing to Stopped to Idle states. This can cause incorrect test results due to improper reuse of reaction vessels (RVs) in the Alinity i Processing Module.
Lab users with Alinity ci series systems running software versions 2.6.0 or 2.6.1 are affected. Those performing clinical chemistry or immunoassay tests are most at risk of inaccurate results.
Check if your Alinity ci series System Control Module has software version 2.6.0 or 2.6.1. All units with these software versions are affected, regardless of serial number.
Install the latest software version to fix the issue with reaction vessel reuse.
Abbott identified that software versions 2.6.0 and 2.6.1 may produce incorrect test results after the system stops and restarts.
No, you can continue using the system but you must update the software to the latest version to prevent incorrect results.
Check the software version on your Alinity ci series System Control Module; affected units run versions 2.6.0 or 2.6.1.
We’ve drafted a message you can send Abbott to request your refund or repair — edit it as you like.
Subject: Recall Z-2363-2019 — Abbott Abbott Hello, I own a Abbott that is covered by recall Z-2363-2019 from Abbott. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
