Abbott Laboratories recalls Alinity ci-series System Control Module (SCM), REF: 03R70-01, 03R70-20

Recall date

November 13, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0961-2026

FDA classification

Class II

Brand / firm

Abbott Laboratories

Sold / distributed

Worldwide distribution: US (nationwide) to states of: AK, AL, AR, AZ, CA, CO, CT, DE, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NH, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, PR; and OUS (foreign) to countries of: Al…

Why it was recalled

Abbott Laboratories is recalling their Alinity ci-series System Control Module, a chemistry/immunoassay anayzer, by correction. The reason for the recall is potential performance issues found in the Alinity ci-series System software versions 3.6.1. and lower that could lead to erroneous results for multiple analytes. The issue was identified by Abbott during the internal testing of complaint investigations.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Alinity ci-series System Control Module (SCM), REF: 03R70-01, 03R70-20