Alinity ci-series System Control Module (SCM), REF: 03R70-01, 03R70-20
FDA device recall Z-0961-2026 · posted 2025-12-18 · Open, Classified
Recall details
- Recalling firm
- Abbott Laboratories
- Reason for recall
- 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.
- Action taken
- 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 Manual until software version 3.7.0 is installed. 4) If you observe a bent pipettor probe (R1, R2), perform the component replacement procedure, Replace the reagent probes (c-series) per Section 9 of the Alinity ci-series Operations Manual. If you have forwarded the product to other laboratories, please inform them of this product correction and provide to them a copy of this letter. If you have questions regarding this information, contact Customer Service at 1-877-4ABBOTT.
- Root cause
- Software design
- Status
- Open, Classified
- Product code
- JJE
- Quantity affected
- 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
- Date initiated
- 2025-11-13
- Date posted
- 2025-12-18
- Location
- Irving, TX
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Alinity i Total ß-hCG Reagent Kit, Alinity i System (K170317) | Abbott Laboratories | 2017-10-23 |
| ALINITY C GLUCOSE REAGENT KIT, ALINITY C SYSTEM (K170316) | Abbott Laboratories | 2017-10-19 |