Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Abbott Alinity m System Recalled by Abbott Molecular, Inc. Due to The instrument was found to be installed without...
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
Abbott Alinity m System, REF 08N53-002, containing Amplification Detetction Unit (ADU) #4.
Quantity: 1
Why Was This Recalled?
The instrument was found to be installed without plunger assemblies in the clamp bar for an Amplification Detection Unit. After correction of the issue, the instrument was returned for use without calibration. This would result in a potential for delay of results and incorrect results.
Where Was This Sold?
This product was distributed to 1 state: PA
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