Abbott Alinity hq Analyzer Software Issue: Incorrect Results When Saturation Present
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.
Lower-risk recall
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.
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What happened, in plain English
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. Read more at govinfonow.com/recall/51262-abbott-alinity-hq-analyzer-software-issue-incorrect-results-when-saturation.
Source Summary by GovInfoNow · govinfonow.com/recall/51262-abbott-alinity-hq-analyzer-software-issue-incorrect-results-when-saturation · Updated August 17, 2026 · FDA enforcement record: FDA #Z-0489-2026
Cite this page
“Abbott Alinity hq Analyzer Software Issue: Incorrect Results When Saturation Present.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/51262-abbott-alinity-hq-analyzer-software-issue-incorrect-results-when-saturation. Based on FDA recall #Z-0489-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0489-2026%22&limit=1).
Why it’s dangerous
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.
Who’s affected
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.
How to tell if you have this one
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.
- Brand
Abbott- Category
Medical device
What to do — step by step
Check Software Version
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.
Update Software
Download and install the updated software version 5.10.1 or later from Abbott's website to fix the issue.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 9 states.
FDA distribution: “Worldwide distribution: US (nationwide) to states of: AL, CA, CO, FL, IN, MN, NC, NY, OK and OUS (foreign) to countries of: ALBANIA, ARGENTINA, AUSTRALIA, BANGLADESH, BELGIUM, BOSNIA AND HERZEGOVINA, BRAZIL, BULGARIA, CANADA, CAYMAN…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, California, Colorado, Florida, Indiana, Minnesota, New York, North Carolina, Oklahoma.
Recall timeline
FDA published this recall 2 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
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.
- Official source: FDA Recall #Z-0489-2026 (September 18, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0489-2026 to see it in context.
- Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.