Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
The Alinity m System Recalled by Abbott Molecular, Inc. Due to Incorrect optical calibration
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
The Alinity m System, REF 08N53-002, For In Vitro Diagnostic Use.
Quantity: 1
Why Was This Recalled?
Incorrect optical calibration
Where Was This Sold?
There was only foreign distribution to Italy.
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