Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Alinity m HBV Application Specification File (US and CE) Recalled by Abbott Molecular, Inc. Due to There is a potential for misquantitation high results...
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 HBV Application Specification File (US and CE)
Why Was This Recalled?
There is a potential for misquantitation high results of negative samples.
Where Was This Sold?
This product was distributed to 14 states: AZ, CA, IL, IN, MA, MI, MO, NH, NJ, NY, OH, SD, TX, VA
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