Abbott recalls Alinity ci-series System Control Module software versions 3.4.0 and lower due to potential erroneous test results. Affected users should check their software version and contact Abbott for updates.
There are potential performance issues found in the Alinity ci-series System software versions 3.4.0 and lower, including: 1) SCC Reagent load error during daily maintenance; 2) Sample Laboratory Report error; 3) Customer requests mechanism to prevent user error when creating new lots of value assigned Calibrators; 4) Error in processing tests after CCCintController encountered an error with the assay information downloaded from SCC; 5) The assay editor does not correctly check sample dilution total volume limits; 6) User-Applied Labels not adhering to Reagent Bottles; 7) ICT Module did not expire after warranty was exceeded. These performance issues could lead to erroneous results for multiple analytes.
Abbott is recalling Alinity ci-series System Control Module software versions 3.4.0 and lower because these versions can cause incorrect test results. This affects labs using the system and could lead to inaccurate medical testing.
The software issues can cause errors in test results, including reagent load errors, sample report errors, and incorrect calibration. These problems might lead to incorrect medical diagnoses if the system is used for critical testing.
Labs using the Alinity ci-series System Control Module with software versions 3.4.0 or lower are affected. Users most at risk are those performing medical testing where inaccurate results could impact patient care.
Check if your Alinity ci-series System Control Module has software version 3.4.0 or lower. The product is identified by the reference number 03R70-01 and UDI-DI: 00380740137410.
Verify your Alinity ci-series System Control Module software version; affected units have version 3.4.0 or lower.
Software versions 3.4.0 and lower are affected.
Check your Alinity ci-series System Control Module software version; affected units have version 3.4.0 or lower.
Contact Abbott for guidance on updating the software to a newer version.
We’ve drafted a message you can send Abbott to request your refund or repair — edit it as you like.
Subject: Recall Z-0613-2024 — Abbott Abbott Hello, I own a Abbott that is covered by recall Z-0613-2024 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.
