Radiometer AutoCheck5+ Level 2 QC Ampoules May Give Incorrect Blood Gas Results
Radiometer America recalls AutoCheck5+ Level 2 QC ampoules for blood gas analyzers that may give incorrect pCO2 and pO2 results. Affected units were sold with specific lot numbers.
Lower-risk recall
Radiometer has recently become aware that a few of the AUTOCHECK 5+ level 2 ampoules, will give incorrect results for pCO2 and pO2. A defective QC ampoule will for: " pCO2 give a result close to or just outside of the low end of the control range. (4.92 5.85 kPa or 36.9 46.9 mmHg) " pO2 give a considerable higher result than the expected assigned value of 13.9 -14.3 kPa (104-107 mmHg)
Contact the company
What happened, in plain English
Radiometer America is recalling AutoCheck5+ Level 2 QC ampoules for blood gas analyzers because they can give incorrect pCO2 and pO2 readings. This could lead to inaccurate blood gas analysis results if used in medical testing. Read more at govinfonow.com/recall/73050-radiometer-autocheck5-level-2-qc-ampoules-may-give-incorrect-blood.
Source Summary by GovInfoNow · govinfonow.com/recall/73050-radiometer-autocheck5-level-2-qc-ampoules-may-give-incorrect-blood · Updated September 18, 2026 · FDA enforcement record: FDA #Z-3237-2017
Cite this page
“Radiometer AutoCheck5+ Level 2 QC Ampoules May Give Incorrect Blood Gas Results.” GovInfoNow, updated September 18, 2026. https://govinfonow.com/recall/73050-radiometer-autocheck5-level-2-qc-ampoules-may-give-incorrect-blood. Based on FDA recall #Z-3237-2017 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3237-2017%22&limit=1).
Why it’s dangerous
Defective QC ampoules may produce pCO2 results close to or just outside the low end of the control range and pO2 results significantly higher than expected values. This could lead to incorrect blood gas analysis results.
Who’s affected
Healthcare professionals using Radiometer blood gas analyzers with the affected QC ampoules. Patients receiving blood gas tests may be at risk of inaccurate results.
How to tell if you have this one
Check for the product name 'AutoCheck5+ Level 2' and lot number R0698 on the ampoule. These ampoules are specifically designed for Radiometer America's blood gas analyzers.
- Brand
Radiometer America- Category
Medical device
What to do — step by step
Check Ampoule Lot Number
Look for lot number R0698 on the ampoule to confirm if it is affected.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “Worldwide Distribution - US (nationwide) Internationally to Canada, Netherlands, China, Czech Republic, Denmark, Germany, Spain France, Hungary, India, Denmark, Tokyo, South Korea, United Kingdom, Australia, Poland, South Africa,…” 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 terminated this recall 23 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
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-3237-2017 (September 7, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-3237-2017 to see it in context.
- Plain-language summary written by qwen3:4b on September 18, 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.