Recall Z-0961-2026 · JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Abbott Laboratories
Alinity ci-series System Control Module (SCM), REF: 03R70-01, 03R70-20
| Date | Dec 18, 2025 (initiated Nov 13, 2025) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Software design |
| Action | On 11/13/2025, "Urgent Field Safety Notice Product Correction" notices were sent to customers who were asked to take the following actions: 1) Perform the Weekly maintenance procedures (i-series) 2630 Manual Wash Cup Cleaning (i-series) per Section 9 of the Alinity ci-series Operations Manual. 2) Field Service Representative will contact you to schedule installation of software version 3.7.0. 3) It is recommended to perform the Pipettor diagnostic procedures (c-series) 4109 Probe Alignment Test (c-series) daily for R1 and R2 pipettor probes per Section 9 of the Alinity ci-series Operations Man |
| Quantity | 11653 |
| Distribution | 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 |
| FDA record | Open on fda.gov |