Use cautionMedical device recall · FDA · Published March 20, 2025
Abbott Alinity m System Recall: Liquid Spill Hazard in Walking Path
Abbott recalls Alinity m System models 08N53-001, 08N53-002, and 08N53-032 (refurbished) due to liquid waste potentially flowing into walking paths. All units with these serial numbers are affected.
The design of the Alinity m System Solutions drawer enclosure may allow liquid (liquid waste or system solutions) originating in the System Solutions drawer to flow beyond the footprint of the instrument and into the walking-path of the user.
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Contact the company
📍Recalling firmAbbott Molecular, Inc.1300 E Touhy Ave · Des Plaines, IL 60018-3315
✎ GovInfoNow plain-language explainer
Abbott is recalling specific models of the Alinity m System, which automates nucleic acid testing. The design may cause liquid waste to spill onto the user's walking path, creating a slip hazard. This recall affects users who have these models and could lead to falls or injuries if not addressed. Read more at govinfonow.com/recall/52590-abbott-alinity-m-system-recall-liquid-spill-hazard-in-walking.
“Abbott Alinity m System Recall: Liquid Spill Hazard in Walking Path.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/52590-abbott-alinity-m-system-recall-liquid-spill-hazard-in-walking. Based on FDA recall #Z-1665-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1665-2025%22&limit=1).
The FDA announced on March 20, 2025, that Abbott Molecular, Inc. is recalling the Alinity m System due to a design flaw that may allow liquid to flow into the user's walking path. The agency issued recall number Z-1665-2025 for the device.
How to tell if you have it
Brand: Abbott
Product: The Alinity m System
Model Numbers: 08N53-001, 08N53-002, 08N53-032 (Refurbished)
Distribution: Worldwide - US Nationwide distribution
The hazard
According to the FDA, the design of the Alinity m System Solutions drawer enclosure may allow liquid, including liquid waste or system solutions, to flow beyond the instrument's footprint and into the user's walking path.
Context
GovInfoNow's records show Abbott Molecular, Inc. has had 19 other recalls since August 4, 2021. Other recent recalls of similar products include Abbott Alinity m Resp-4-Plex AMP Kit Recall (2025-04-28), Abbott Alinity m HPV Kit Recall (2024-09-12), and Abbott Alinity m System: Error 6013 with Copan UTM Tubes (2024-03-20). Other recent recalls of similar products include Medline Medical Kits Recall: Particulate Risk in Fluid Path (2026-03-24), Medline Medical Kits Recall: Particulate in Fluid Path Risk (2026-03-24), and Medline medical convenience kits with particulate in fluid path recalled (2026-03-24).
How to tell if you have this one
Check for model numbers 08N53-001, 08N53-002, or 08N53-032 (refurbished) on the device. All units with these serial numbers are affected, as indicated by their Unique Device Identifiers (UDIs).
Brand
Abbott
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Model Numbers
Identify the model number on your Alinity m System to see if it is 08N53-001, 08N53-002, or 08N53-032 (refurbished).
Review Serial Numbers
Check the serial number on your device, which is linked to the Unique Device Identifier (UDI) provided in the recall notice.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Worldwide - US Nationwide distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 41 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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-1665-2025 (March 20, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1665-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 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.