Beckman Coulter AQUIOS CL Flow Cytometer Recall: Sample Misidentification Risk
Beckman Coulter recalls AQUIOS CL Flow Cytometers (Catalog B30166) due to potential sample misidentification when connected to laboratory systems. Affected units may require correction to prevent diagnostic errors.
Lower-risk recall
The system may duplicate sample requests leading to sample misidentification when connected to a Laboratory Information System (LIS)
Contact the company
What happened, in plain English
Beckman Coulter is recalling AQUIOS CL Flow Cytometers that could misidentify samples when connected to laboratory information systems. This risk could lead to incorrect diagnostic results if the device is used in a lab setting. Read more at govinfonow.com/recall/72922-beckman-coulter-aquios-cl-flow-cytometer-recall-sample-misidentification-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/72922-beckman-coulter-aquios-cl-flow-cytometer-recall-sample-misidentification-risk · Updated September 17, 2026 · FDA enforcement record: FDA #Z-0091-2018
Cite this page
“Beckman Coulter AQUIOS CL Flow Cytometer Recall: Sample Misidentification Risk.” GovInfoNow, updated September 17, 2026. https://govinfonow.com/recall/72922-beckman-coulter-aquios-cl-flow-cytometer-recall-sample-misidentification-risk. Based on FDA recall #Z-0091-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0091-2018%22&limit=1).
Why it’s dangerous
The device may duplicate sample requests when connected to a Laboratory Information System (LIS), causing sample misidentification. This could lead to incorrect diagnostic results if the device is used in a lab setting.
Who’s affected
Laboratory users with the AQUIOS CL Flow Cytometer (Catalog B30166) are most at risk. This affects labs that connect the device to laboratory information systems.
How to tell if you have this one
Check for the AQUIOS CL Flow Cytometer with Catalog Number B30166. The label shows 'Beckman Coulter Ireland Inc., Ireland' as the manufacturer.
- Brand
Beckman Coulter- Category
Medical device
What to do — step by step
Check Device Settings
Verify the device is not connected to a Laboratory Information System (LIS) before use to prevent sample misidentification.
Where it went and when
Where it was distributed
Distributed in 15 states and Puerto Rico, and outside the U.S.
FDA distribution: “Worldwide Distribution - US Distribution to the states of : AZ, CA, CO, FL, GA, IL, IN, KS, NC, NY, OR, PA, SC, TX, and WA, including Puerto Rico and government distribution, and to the countries of : Canada, Angola, Australia, Belgium,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Arizona, California, Colorado, Florida, Georgia, Illinois, Indiana, Kansas, New York, North Carolina, Oregon, Pennsylvania, Puerto Rico, South Carolina, Texas, Washington.
Recall timeline
FDA terminated this recall 19 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-0091-2018 (October 2, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0091-2018 to see it in context.
- Plain-language summary written by qwen3:4b on September 17, 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.