Abbott recalls Alinity hq Analyzer models 09P68-01 software versions 5.0 to 5.10.1 (US) and 5.7 to 5.10.1 (OUS) due to potential incorrect results when saturation occurs. Affected units may need software update.
Software issue for hq analyzer results in system not visibly applying appropriate flagging to results when saturation is present which may result in incorrect results.
Abbott is recalling Alinity hq Analyzers with model 09P68-01 and software versions 5.0 to 5.10.1 (US) or 5.7 to 5.10.1 (outside US) because a software issue can cause the device to fail to flag results properly when saturation is present, potentially leading to incorrect test results. This does not pose an immediate safety risk but could affect test accuracy.
The software issue causes the analyzer to not visibly apply appropriate flagging when saturation is detected in samples. This means that if a sample is saturated, the device might not alert the user, potentially leading to incorrect test results that could affect diagnosis and treatment decisions.
Users of Alinity hq Analyzers with model 09P68-01 and software versions 5.0 to 5.10.1 (US) or 5.7 to 5.10.1 (outside US) are affected. Laboratory staff and healthcare providers using these analyzers are most at risk of inaccurate test results.
Check if your Alinity hq Analyzer has model number 09P68-01 and software version 5.0 to 5.10.1 (US) or 5.7 to 5.10.1 (outside US). The device may have a unique serial number or part number listed in the product description.
Verify your Alinity hq Analyzer's software version by checking the device settings or manual. If it is 5.0 to 5.10.1 (US) or 5.7 to 5.10.1 (outside US), it is affected.
Download and install the updated software version 5.10.1 or later from Abbott's website to fix the issue.
No, this recall does not pose a safety risk but could lead to inaccurate test results if the software issue is not corrected.
Check if your device has model number 09P68-01 and software version 5.0 to 5.10.1 (US) or 5.7 to 5.10.1 (outside US).
No, you can continue using it but you must update the software to version 5.10.1 or later to prevent incorrect results.
We’ve drafted a message you can send Abbott to request your refund or repair — edit it as you like.
Subject: Recall Z-0489-2026 — Abbott Abbott Hello, I own a Abbott that is covered by recall Z-0489-2026 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.
