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.
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.
The Alinity m System's Solutions drawer enclosure design may allow liquid waste or system solutions to flow beyond the instrument's footprint. This liquid could spill onto the user's walking path, increasing the risk of slips and falls.
Users of the Alinity m System models 08N53-001, 08N53-002, and 08N53-032 (refurbished) are affected. Laboratory staff and healthcare workers using these systems are most at risk due to potential liquid spills.
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).
Identify the model number on your Alinity m System to see if it is 08N53-001, 08N53-002, or 08N53-032 (refurbished).
Check the serial number on your device, which is linked to the Unique Device Identifier (UDI) provided in the recall notice.
The Alinity m System models 08N53-001, 08N53-002, and 08N53-032 (refurbished) are affected.
Check for model numbers 08N53-001, 08N53-002, or 08N53-032 (refurbished) on the device. All units with these serial numbers are affected.
The recall does not specify a remedy, so contact Abbott directly for guidance on next steps.
We’ve drafted a message you can send Abbott to request your refund or repair — edit it as you like.
Subject: Recall Z-1665-2025 — Abbott Abbott Hello, I own a Abbott that is covered by recall Z-1665-2025 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.
