Radiometer ABL800 Analyzer Recall: Software Mismatch Risk

Take action

Contact the company & request your remedy

Recalling firmRadiometer America Inc250 S Kraemer Blvd · Brea, CA 92821-6232

No email on file — write to the address above instead.

✎ GovInfoNow plain-language explainer

What happened, in plain English

Radiometer is recalling ABL800 analyzers with model numbers 393-800 and 393-801. The software may cause patient demographic and test results to mismatch under certain conditions, which could lead to incorrect medical decisions.

Why it’s dangerous

The software may mismatch patient demographic information with test results when specific sequences of events happen. This could lead to incorrect medical decisions if the mismatch affects patient care.

Who’s affected

Healthcare facilities using the ABL800 analyzers with model numbers 393-800 or 393-801 are most at risk. Patients receiving tests on these devices may experience incorrect results if the software issue occurs.

How to tell if you have this one

Check for model numbers 393-800 or 393-801 on the ABL800 analyzer. Affected units include specific configurations with creatinin for models 393-800 and 393-801.

Brand
Radiometer
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Model Numbers
Identify the model number on your ABL800 analyzer to see if it is 393-800 or 393-801.

✎ GovInfoNow

Questions people ask

What is the software issue with the ABL800 analyzers?

The software may cause patient demographic information and test results to mismatch when certain sequences of events occur.

Which models are affected?

Model numbers 393-800 and 393-801 for the ABL800 analyzer, including specific configurations with creatinin.

Do I need to stop using the device?

The recall does not require immediate stop use; affected units may continue operation but should be checked for the software issue.

Take action

Contact Radiometer

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

✉️ Open in email

Subject: Recall Z-0682-2019 — Radiometer Radiometer

Hello,

I own a Radiometer that is covered by recall Z-0682-2019 from Radiometer.

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.

Similar recalls

From people who’ve dealt with this

Experiences, tips, and questions from readers. Every comment is reviewed before it appears.

No comments yet — be the first to share your experience.

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-0682-2019 (July 3, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0682-2019 to see it in context.
Plain-language summary written by qwen3:4b on August 20, 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.

Radiometer America Inc recalls ABL800 analyzer, model numbers 393-800 and 393-801.

Lower-risk recall