Radiometer ABL800 FLEX Analyzers: Calibration Solution pH Issue
Radiometer recalls ABL800 FLEX analyzers with model numbers 393-800 and 393-801 due to potential pH bias from bacterial growth in calibration solutions. Users should check their device model and contact Radiometer for remediation.
Lower-risk recall
Issue with analyzer when the pH of the calibration solution decreases during the in-use period potentially because of bacterial growth in the calibration solution bottles. This may result in a probability of reporting biased out-of-specification pH results on blood samples.
Contact the company
What happened, in plain English
Radiometer is recalling specific models of ABL800 FLEX analyzers because bacterial growth in calibration solutions can cause inaccurate pH readings on blood samples. This means test results might be wrong, but the risk is low if you follow proper cleaning and calibration procedures. Read more at govinfonow.com/recall/54952-radiometer-abl800-flex-analyzers-calibration-solution-ph-issue.
Source Summary by GovInfoNow · govinfonow.com/recall/54952-radiometer-abl800-flex-analyzers-calibration-solution-ph-issue · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2426-2024
Cite this page
“Radiometer ABL800 FLEX Analyzers: Calibration Solution pH Issue.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/54952-radiometer-abl800-flex-analyzers-calibration-solution-ph-issue. Based on FDA recall #Z-2426-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2426-2024%22&limit=1).
Why it’s dangerous
Bacterial growth in the calibration solution bottles can lower the pH during use, which may cause the analyzer to report inaccurate pH results on blood samples. This could lead to incorrect medical decisions if the test results are relied upon.
Who’s affected
Users of Radiometer ABL800 FLEX analyzers with model numbers 393-800 or 393-801 are affected. Healthcare professionals using these devices for blood testing are most at risk.
How to tell if you have this one
Check if your ABL800 FLEX analyzer has model numbers 393-800 or 393-801. The device is intended for in vitro testing of blood samples and expired air.
- Brand
Radiometer- Product
ABL800 FLEX Model Numbers 393-800 and 393-801 The ABL800 FLEX analyzers are intended for: " In Vitro testing of samples- Category
Medical device
What to do — step by step
Check your model number
Look for model numbers 393-800 or 393-801 on your ABL800 FLEX analyzer.
Contact Radiometer
Reach out to Radiometer Medical ApS for further instructions on remediation.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 43 states.
FDA distribution: “Worldwide - U.S. Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, SD, TN, TX, UT, VA, WA, WI, WV,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, West Virginia, Wisconsin, Wyoming.
Recall timeline
FDA published this recall 2 months 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.
Questions people ask
Do I need to stop using this device?
No, you do not need to stop using it immediately. Radiometer recommends checking your model number and contacting them for remediation steps.
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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-2426-2024 (May 31, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2426-2024 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.