Beckman Coulter AQUIOS CL Flow Cytometer Recall: Incorrect Settings Cause Wrong Lab
Beckman Coulter recalls AQUIOS CL Flow Cytometers with specific serial numbers due to software settings causing incorrect patient test results. Affected units may report wrong lab values for some samples.
Lower-risk recall
Beckman Coulter has identified that an incorrect setting using a proprietary software configuration tool can result in the Sample Prep Probe of the AQUIOS CL drawing aspirant from the wrong tube in a cassette which manifests in incorrect values being reported out of the laboratory for some patient samples.
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What happened, in plain English
Beckman Coulter is recalling AQUIOS CL Flow Cytometers with certain serial numbers because incorrect software settings can cause the device to draw samples from the wrong tubes, leading to inaccurate lab results for some patient tests. This could affect the accuracy of medical diagnoses. Read more at govinfonow.com/recall/73131-beckman-coulter-aquios-cl-flow-cytometer-recall-incorrect-settings-cause.
Source Summary by GovInfoNow · govinfonow.com/recall/73131-beckman-coulter-aquios-cl-flow-cytometer-recall-incorrect-settings-cause · Updated September 18, 2026 · FDA enforcement record: FDA #Z-3135-2017
Cite this page
“Beckman Coulter AQUIOS CL Flow Cytometer Recall: Incorrect Settings Cause Wrong Lab.” GovInfoNow, updated September 18, 2026. https://govinfonow.com/recall/73131-beckman-coulter-aquios-cl-flow-cytometer-recall-incorrect-settings-cause. Based on FDA recall #Z-3135-2017 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3135-2017%22&limit=1).
Why it’s dangerous
The device's software can be set incorrectly, causing it to draw samples from the wrong tubes in a lab cassette. This leads to inaccurate lab results for some patient samples, potentially affecting medical diagnoses.
Who’s affected
Healthcare facilities using the AQUIOS CL Flow Cytometer for lab testing are most at risk, particularly those with the listed serial numbers. Patients receiving tests on affected units may receive incorrect results.
How to tell if you have this one
Check the serial number on your AQUIOS CL Flow Cytometer. The affected units have specific serial numbers listed in the recall notice, including BA30048, AY20032, and others.
- Brand
Beckman Coulter- Category
Medical device
What to do — step by step
Check Serial Number
Look for the serial number on your AQUIOS CL Flow Cytometer to see if it matches the list of affected units provided in the recall.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “Worldwide Distribution: United States (nationwide) and countries of: Angola, Australia, Botswana, Canada, Chile, Columbia, Ghana, Israel, Malaysia, Namibia, Pakistan, Panama, South Africa, Uganda, France, Switzerland, Poland, Portugal,…” 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 6.1 years 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-3135-2017 (August 21, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-3135-2017 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.