Radiometer ABL90 FLEX Analyzers with Windows 10 RWIN10 1.0/1.1 May Freeze During Tests
Radiometer ABL90 FLEX analyzers with Windows 10 versions RWIN10 1.0 and RWIN10 1.1 may unexpectedly freeze during sample measurements, causing test delays. Affected units include specific model numbers and serials listed in the recall.
Lower-risk recall
ABL90 FLEX and ABL90 FLEX PLUS analyzers running with Radiometer Windows 10 versions RWIN10 1.0 and RWIN10 1.1 may unexpectedly freeze (the analyzer ceases to operate) during a sample measurement. The analyzer software includes a feature (watchdog) that detects a freeze and automatically restarts the software to continue operating the analyzer. However, even if a restart occurs, any sample being processed at that time will be lost, potential to lead to delay in test results.
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What happened, in plain English
Radiometer ABL90 FLEX and ABL90 FLEX PLUS analyzers with Windows 10 versions RWIN10 1.0 and RWIN10 1.1 may freeze during sample measurements. Even after restarting, samples being processed at the time will be lost, potentially delaying test results. This recall affects specific model numbers and serials. Read more at govinfonow.com/recall/52580-radiometer-abl90-flex-analyzers-with-windows-10-rwin10-1-0.
Source Summary by GovInfoNow · govinfonow.com/recall/52580-radiometer-abl90-flex-analyzers-with-windows-10-rwin10-1-0 · Updated August 18, 2026 · FDA enforcement record: FDA #Z-1659-2025
Cite this page
“Radiometer ABL90 FLEX Analyzers with Windows 10 RWIN10 1.0/1.1 May Freeze During Tests.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/52580-radiometer-abl90-flex-analyzers-with-windows-10-rwin10-1-0. Based on FDA recall #Z-1659-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1659-2025%22&limit=1).
Why it’s dangerous
The analyzer software includes a watchdog feature that detects freezes and automatically restarts the software. However, any samples being processed during a freeze are lost, which can delay test results. This does not cause injury but may lead to delays in critical medical testing.
Who’s affected
Healthcare professionals using these analyzers in labs, near patients, or point-of-care settings are most at risk. The recall affects specific model numbers and serials listed in the notice.
How to tell if you have this one
Check for model numbers 393-090 or 393-092 on the device. Affected units have specific serial numbers listed in the recall notice, including those starting with 090R or 092R.
- Brand
Radiometer- Category
Medical device
What to do — step by step
Check Device Model
Look for model numbers 393-090 or 393-092 on the analyzer.
Verify Serial Number
Confirm the serial number is listed in the provided recall list (e.g., 090R0643N002, 092R0150N001).
Where it went and when
Where it was distributed
Distributed in 47 states and D.C. and Puerto Rico, and outside the U.S.
FDA distribution: “U.S.: AL, AR, AZ, BM CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV, and WY. O.U.S.: Canada, Afghanistan,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Alabama, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming.
Recall timeline
FDA published this recall 40 days 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.
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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-1659-2025 (March 21, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1659-2025 to see it in context.
- Plain-language summary written by qwen3:4b on August 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.