Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Alinity m System Recalled by Abbott Molecular, Inc. Due to There is a software issue associated with the...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Abbott Molecular, Inc. directly.
Affected Products
Alinity m System, Part No. 08N53-002
Quantity: 742 devices
Why Was This Recalled?
There is a software issue associated with the ability to properly complete a Field Service Engineer Maintenance and Diagnostics procedure.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Abbott Molecular, Inc.
Abbott Molecular, Inc. has 30 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report