Abbott Alinity i Software Version 2.6.2 Recalled for Performance Issues

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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 i devices with software version 2.6.2 and earlier because of potential performance issues. This could affect device accuracy or reliability in clinical settings.

Why it’s dangerous

The software version 2.6.2 and earlier may cause performance issues that could affect the device's accuracy or reliability in clinical settings. This might lead to incorrect results or delayed testing.

Who’s affected

Healthcare professionals using the Alinity i device with the specified software version are most at risk. Patients using the device may also be affected if the device's performance is impacted.

How to tell if you have this one

Check if your Alinity i device has software version 2.6.2 or earlier. The device uses the Alinity i (LN 03R65-01) or Alinity c (LN 03R67-01) processing modules.

Brand
Abbott
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Software Version
Verify your device's software version by checking the device settings or manual.

✎ GovInfoNow

Questions people ask

What software versions are affected?

Software versions 2.6.2 and earlier are affected.

How do I know if my device is affected?

Check if your Alinity i device has software version 2.6.2 or earlier, as this version is used with the Alinity i (LN 03R65-01) or Alinity c (LN 03R67-01) processing modules.

What should I do if my device is affected?

The recall does not specify a remedy, so contact Abbott directly 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-1580-2020 — Abbott Abbott

Hello,

I own a Abbott that is covered by recall Z-1580-2020 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-1580-2020 (January 24, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1580-2020 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 LN 3R70-01; software version 2.6.2 and earlier. The software is used with the Alinity i (LN 03R65-01) processing module

Lower-risk recall