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 defect that can cause...
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 defect that can cause the Amplification Detection clamp CLEAN position to be set too high.
Where Was This Sold?
Worldwide distribution - US distribution and the countries of Australia, Austria, Belgium, Brazil, Cambodia, Canada, Chile, Colombia, Czech Republic, Egypt, El Salvador, Estonia, Finland, France, Germany, Hong Kong, Ireland, Israel, Italy, Japan, Malawi, Malaysia, Mexico, Montenegro, Morocco, Mozambique, Netherlands, New Zealand, Norway, Pakistan, Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Uganda, United Kingdom, and Vietnam
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