Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Abbott Alinity m SARS-CoV-2 CTRL Kit Recalled by Abbott Molecular, Inc. Due to Reports received of an increase of message code...
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 SARS-CoV-2 CTRL Kit, REF 09N78-085, each kit contains 12 x 1.3mL CTRL - and 12 x 1.3 mL CTRL +, For In Vitro Diagnostic Use.
Quantity: 579 kits
Why Was This Recalled?
Reports received of an increase of message code 9186 (internal control failed) when using the kit.
Where Was This Sold?
This product was distributed to 24 states: AZ, CA, CT, FL, GA, IL, KS, KY, LA, MA, MI, MN, MO, NV, NJ, NY, NC, OK, PA, RI, TN, TX, WA, WI
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