Abbott Alinity ci System Control Module Software Recalls: QC Failures Risk

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Recalling firmAbbott Gmbh & Co. KGMax-Planck-Ring 2, 65205 · Wiesbaden, N/A N/A

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✎ GovInfoNow plain-language explainer

What happened, in plain English

Abbott is recalling Alinity ci series System Control Module software versions 3.1.1 and below because quality control results weren't properly evaluated for QC failures. This could lead to inaccurate test results if the software is used.

Why it’s dangerous

The software versions 3.1.1 and below did not properly evaluate quality control results. This could lead to inaccurate test results if the system is used for medical testing. The hazard does not involve physical harm or system failure.

Who’s affected

Users of Alinity ci series System Control Module with software versions 3.1.1 and below are affected. Laboratory personnel who use this equipment for medical testing are most at risk.

How to tell if you have this one

Check if your Alinity ci series System Control Module has software version 3.1.1 or below. The recall includes all serial numbers of the System Control Module.

Brand
Abbott
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Software Version
Verify your Alinity ci series System Control Module software version. Versions 3.1.1 and below are affected.

✎ GovInfoNow

Questions people ask

What software versions are affected?

Software versions 3.1.1 and below are affected.

How can I tell if my system is affected?

Check if your Alinity ci series System Control Module has software version 3.1.1 or below. The recall includes all serial numbers of the System Control Module.

What should I do if my system is affected?

The recall does not specify a remedy. Check with Abbott for further instructions.

Take action

Contact Abbott

We’ve drafted a message you can send Abbott to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall Z-2701-2020 — Abbott Abbott

Hello,

I own a Abbott that is covered by recall Z-2701-2020 from Abbott.

I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this?

Thank you.

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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-2701-2020 (June 19, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2701-2020 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.

Abbott Gmbh & Co. KG recalls Alinity ci series System Control Module (SCM); LN 3R70-01 Alinity ci series software versions, 3.1.1 and below

Lower-risk recall