Abbott Laboratories recalls Brand Name: Alinity hq Analyzer Product Name: Alinity hq Analyzer Model/Catalog Numbe…

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.

On September 18, 2025, Abbott Laboratories issued an "Urgent Medical Device Recall" Notification. Abbott ask consignees to take the following actions: 1. If IG/%IG is above your laboratory established reference range (e.g. greater than 2%), review the results per your laboratory procedures. A manual smear review may need to be performed to confirm the results. 2. Complete and return the Customer Reply Form. 3. If you have forwarded the product listed above to other laboratories, please inform them of this Product Correction and provide to them a copy of this letter. 4. Please retain this letter for your laboratory records. If the problem persists, contact your Abbott representative or Abbott Technical Support (1-800-727-7846) for help to determine whether the inability to communicate is related to this issue.

• FDA enforcement recordOfficial FDA database entry for Z-0489-2026
• FDA 510(k) clearance · K220031The device's official FDA premarket clearance record
• FDA 510(k) clearance · K243283The device's official FDA premarket clearance record
• FDA device classification · GKZOfficial FDA classification for this device type
• CFR regulation · 21 CFR 864.5220The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Abbott LaboratoriesSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.