Abbott Alinity s System Software Version 2.8.0 Recall: Incorrect Wash Buffer Usage
Abbott recalls Alinity s System software version 2.8.0 (serials AS1001-AS1368) due to wash buffer error causing potential inaccurate test results. This is an in vitro diagnostic device.
Lower-risk recall
Software error associated with the immunoassay analyzer wash cycle which is using 1 mL of wash buffer instead of the intended 3 mL of wash buffer to wash the exterior of the probe.
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What happened, in plain English
Abbott is recalling Alinity s System software version 2.8.0 for a wash buffer error that uses 1 mL instead of 3 mL of buffer. This could lead to inaccurate test results for in vitro diagnostics. Read more at govinfonow.com/recall/61183-abbott-alinity-s-system-software-version-2-8-0-recall.
Source Summary by GovInfoNow · govinfonow.com/recall/61183-abbott-alinity-s-system-software-version-2-8-0-recall · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0749-2022
Cite this page
“Abbott Alinity s System Software Version 2.8.0 Recall: Incorrect Wash Buffer Usage.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61183-abbott-alinity-s-system-software-version-2-8-0-recall. Based on FDA recall #Z-0749-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0749-2022%22&limit=1).
Why it’s dangerous
The software error causes the system to use 1 mL of wash buffer instead of the required 3 mL during the probe wash cycle. This incorrect buffer usage can lead to inaccurate test results for in vitro diagnostic tests.
Who’s affected
Users of the Alinity s System (serial numbers AS1001 through AS1368) who perform in vitro diagnostic tests may be affected. Healthcare professionals using this device for lab testing are most at risk.
How to tell if you have this one
Check if your Alinity s System has software version 2.8.0, identified by serial numbers AS1001 through AS1368. The device is intended for in vitro diagnostic use only.
- Brand
Abbott- Product
Alinity s System software version2.8.0, REF LN 06P16-01, IVD, OEI: (01)00380740138479 The Alinity s System is intended- Category
Medical device
What to do — step by step
Update Software
Contact Abbott to update to the corrected software version 2.8.1 or later.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 17 states.
FDA distribution: “Worldwide distribution: US (nationwide) including states of: AL, CA, GA, IL, IN, MN, MO, NC, OK, PA, RI, SC, TN, TX, WA, WI, MD and countries (OUS) including of: Australia, Austria, Bahrain, Belgium, Brazil, china, Colombia, Croatia,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, California, Georgia, Illinois, Indiana, Maryland, Minnesota, Missouri, North Carolina, Oklahoma, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Washington, Wisconsin.
Recall timeline
FDA published this recall 48 days 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-0749-2022 (February 3, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0749-2022 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 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.