Abbott Alinity ci-series System Control Module Software Version 3.2.3 and Earlier Recalled
Abbott recalls Alinity ci-series System Control Module units with software versions 3.2.3 and earlier due to potential performance issues including incorrect reagent status displays, damaged connectors, and sample processing errors. Affected units have specific serial numbers and model numbers.
Lower-risk recall
Due to potential performance issues with software version 3.2.3 and earlier. Performance issues are: 1) There is the potential for onboard reagents past their lot expiration date or onboard stability time to be incorrectly displayed on the Reagent Status screen with a status of "OK". In this scenario, the expired reagent will remain in the carousel for sample processing. 2) Performing monthly maintenance procedure 5701 Clean ICT Drain Tip incorrectly may potentially cause issues such as damaged connector or leaking connection. 3) A sample exception with message code 150 "Unable to process test. Previous processing module error" is produced without notifying the operator of a reagent pipettor failure and may cause processing module to transition into the Pausing state. Tests initiated prior to the sample exception may continue to process without dispense of reagents, potentially leading to incorrect results. 4. Reagent short dispense: Alinity c needs a control measure to protect against the potential for short reagent dispense. Addition of a maximum depth limit for reagent cartridges on the Alinity c to prevent the potential for a short dispense is needed. 5. RSM indicators were blinking green incorrectly: The Reagent and Sample Manager (RSM) indicators will incorrectly blink green indicating that processing is completed and the rack or cartridge can be removed from the loading area when the rack or cartridge should not be accessed. 6. Erroneous ICT Calibration Curves: Erroneous ICT calibration curves might be generated for the Alinity c when there is a malfunction of ICT reference solution delivery, use of wrong/evaporated calibrator, defective ICT modules, etc.
Contact the company
What happened, in plain English
Abbott is recalling Alinity ci-series System Control Modules with software versions 3.2.3 and earlier because they may display expired reagents as 'OK', cause damaged connectors during maintenance, or lead to incorrect test results. This could affect lab results and equipment safety. Read more at govinfonow.com/recall/62155-abbott-alinity-ci-series-system-control-module-software-version-3.
Source Summary by GovInfoNow · govinfonow.com/recall/62155-abbott-alinity-ci-series-system-control-module-software-version-3 · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2472-2021
Cite this page
“Abbott Alinity ci-series System Control Module Software Version 3.2.3 and Earlier Recalled.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62155-abbott-alinity-ci-series-system-control-module-software-version-3. Based on FDA recall #Z-2472-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2472-2021%22&limit=1).
Why it’s dangerous
The software issues can cause the system to incorrectly show expired reagents as 'OK', leading to expired reagents being used. Performing certain maintenance procedures may damage connectors, and sample processing errors could result in incorrect test results without proper warnings.
Who’s affected
Healthcare labs and clinical testing facilities that use the Alinity ci-series System Control Module with software versions 3.2.3 and earlier are most at risk. Individuals with the affected units should check their serial numbers.
How to tell if you have this one
Check if your Alinity ci-series System Control Module has software version 3.2.3 or earlier. Affected units have model number LN 03R70-01 and serial numbers starting with SCM (e.g., SCM01001 to SCM04259).
- Brand
Abbott- Category
Medical device
What to do — step by step
Check Software Version
Verify your software version by checking the device settings or documentation. If it's 3.2.3 or earlier, it's affected.
Contact Abbott
Reach out to Abbott Laboratories for instructions on how to update the software or return the device if needed.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “Worldwide distribution. US nationwide including Puerto Rico; Albania, Algeria, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Bermuda, Bosnia and Herzegovina, Botswana, Brazil, Brunei, Bulgaria, Burkina Faso, Canada, Chile,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 58 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-2472-2021 (July 26, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2472-2021 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.