Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Abbott Alinity ci-series System Control Module software version 2.5.1 Recalled by Abbott Gmbh & Co. KG Due to Potential performance issues in the Alinity-ci software version...
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 Gmbh & Co. KG directly.
Affected Products
Abbott Alinity ci-series System Control Module software version 2.5.1; LN 3R70-01 with the following hardware: Level Sensor, Bulk Solution; 04S68-01, Accessory Kit, Alinity I; 03R66-01and 03R66-02 , and Accessory Kit, Alinity c; 03R69-01 and 03R69-02. Product Usage: The Alinity i (LN 03R65 01) processing module is a fully automated immunoassay analyzer allowing random and continuous access, as well as priority and automated retest processing using chemiluminescent microparticle immunoassay (CMIA) technology. CMIA technology is used to determine the presence of antigens, antibodies, and analytes in samples. The Alinity c (LN 03R67 01) processing module is a fully automated chemistry analyzer allowing random and continuous access, as well as priority and automated retest processing using photometric and potentiometric detection technology. The Alinity c processing module uses photometric detection technology to measure sample absorbance for the quantification of analyte concentration and uses potentiometric detection technology to measure the electrical potential in a sample. In addition, the Alinity c processing module uses an integrated chip technology (ICT) module to measure potentiometric assays (electrolytes).
Quantity: 1557
Why Was This Recalled?
Potential performance issues in the Alinity-ci software version 2.5.1
Where Was This Sold?
This product was distributed to 18 states: AZ, AR, CA, FL, GA, IL, ME, MA, MN, MO, NY, OK, SC, TN, TX, UT, VA, WI
About Abbott Gmbh & Co. KG
Abbott Gmbh & Co. KG has 18 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report