Abbott recalls Alinity ci-series System Control Module software version 2.5.1 (LN 3R70-01) due to potential performance issues. Affected units include specific hardware components for Alinity i and Alinity c analyzers.
Potential performance issues in the Alinity-ci software version 2.5.1
Abbott is recalling software version 2.5.1 for its Alinity ci-series System Control Module. This update may cause performance issues with the device, which is used for medical testing. Users should check if their device matches the described hardware to determine if they are affected.
The software version 2.5.1 may cause performance issues with the Alinity ci-series System Control Module. This could affect the accuracy or reliability of medical test results, though the record does not specify serious injury risks.
Users of Abbott Alinity i and Alinity c analyzers with specific hardware components (Level Sensor, Bulk Solution, Accessory Kits) that were sold with software version 2.5.1 are likely affected. Healthcare facilities using these devices may be at higher risk.
Check if your Alinity i (LN 03R65 01) or Alinity c (LN 03R67 01) device has the System Control Module software version 2.5.1 (LN 3R70-01) with the listed hardware components.
Verify your Alinity ci-series device's software version by checking the system control module label for version 2.5.1 (LN 3R70-01).
The recall states potential performance issues but does not mention risks of serious injury or death. This is considered low risk.
Affected hardware includes Level Sensor, Bulk Solution, Accessory Kit for Alinity i (LN 04S68-01), and Accessory Kit for Alinity c (LN 03R66-01 and 03R66-02).
The recall does not specify a remedy, so no action is required unless you have the affected software version and hardware components.
We’ve drafted a message you can send Abbott to request your refund or repair — edit it as you like.
Subject: Recall Z-1316-2019 — Abbott Abbott Hello, I own a Abbott that is covered by recall Z-1316-2019 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.
