# FDA recall Z-0961-2026

> **Abbott Laboratories** · Class II · device recall initiated 2025-11-13.

## Product

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

## 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.

## 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: Albania, Algeria, Andorra, Argentina, Australia, Austria, Azerbaijan, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Bosnia and Herzegovina, Botswana, Brazil, Brunei, Bulgaria, Cambodia, Cameroon, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, El Salvador, Estonia, Ethiopia, Faroe Islands, Finland, France, Gaza & Jericho, Georgia, Germany, Greece, Greenland, Guatemala, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Jamaica, Japan, Kazakhstan, Kenya, Kosovo, Kuwait, Kyrgyzstan, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malawi, Malaysia, Maldives, Malta, Mauritania, Mauritius, Mexico, Moldova, 

## Key facts

- **Recall number:** Z-0961-2026
- **Recalling firm:** Abbott Laboratories
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-11-13
- **Report date:** 2025-12-24

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Irving, TX, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0961-2026

## Citation

> AI Analytics. FDA recall Z-0961-2026. Retrieved 2026-09-08 from https://api.ai-analytics.org/recall/Z-0961-2026. Source: US FDA. Licensed CC0.

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