Lower riskMedical device recall · FDA · Published November 26, 2025
Beckman Coulter UniCel Dxl 600: May not restart after shutdown causing delayed test
Beckman Coulter recalls UniCel Dxl 600 analyzers with specific part numbers that may not restart after shutdown, leading to delayed patient test results. Affected units require immediate action to prevent incomplete testing.
Beckman Coulter has determined that, due to a potential communication issue, the analyzers listed above may not successfully restart following a standard shutdown, even after multiple attempts. If this issue occurs, the instrument will be unable to complete initialization and transition to Ready mode and the instrument will not process patient samples, QCs or calibrators. This causes delayed results.
Take action
Contact the company
📍Recalling firmBeckman Coulter, Inc.1000 Lake Hazeltine Dr · Chaska, MN 55318-1037
✎ GovInfoNow plain-language explainer
Beckman Coulter is recalling UniCel Dxl 600 analyzers with specific part numbers because they may not restart properly after shutdown, causing delayed test results. This means the equipment might not process patient samples, quality controls, or calibrators correctly. Read more at govinfonow.com/recall/50588-beckman-coulter-unicel-dxl-600-may-not-restart-after-shutdown.
“Beckman Coulter UniCel Dxl 600: May not restart after shutdown causing delayed test.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/50588-beckman-coulter-unicel-dxl-600-may-not-restart-after-shutdown. Based on FDA recall #Z-1025-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1025-2026%22&limit=1).
Beckman Coulter, Inc. recalled Beckman Coulter UniCel Dxl 600 analyzers due to a potential communication issue that may prevent the instruments from restarting after shutdown, according to the FDA on 2025-11-26.
How to tell if you have it
Brand: Beckman Coulter
Product: Beckman Coulter UniCel Dxl 600
Part numbers: A71460, A71461, A30260
Method: Immunoassay Method, Troponin Subunit
Quantity: 1272 units
The hazard
The analyzers may not successfully restart following a standard shutdown, even after multiple attempts. If this occurs, the instrument will be unable to complete initialization and transition to Ready mode, causing delayed results for patient samples, QCs, or calibrators.
Context
GovInfoNow's records show Beckman Coulter, Inc. has had 132 other recalls since 2017-06-20. Recent brand recalls include the Beckman Coulter DxC 500 AU Modules recall on 2026-07-15 and the Beckman Coulter MicroScan LabPro V5.03 Panel Update 11 DVD Kit recall on 2026-06-26. Other recent recalls of similar products include the Beckman Coulter DxC 700 AU Recall (2026-01-30) and the Beckman Coulter AU5800 Chemistry Analyzer Recall (2026-01-30).
How to tell if you have this one
Check for part numbers A71460, A71461, or A30260 on the analyzer. The UniCel Dxl 600 is used for troponin subunit immunoassay testing and was sold with specific unique device identifiers (UDIs).
Brand
Beckman Coulter
Category
Medical device
FDA recall event · 2 products
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Ongoing
Distribution
Worldwide Distribution: US (nationwide) and OUS (foreign) to countries of: Albania, Algeria, Argentina, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bosnia and Herzegovina, Botswana, Brazil, Bulgaria, Cabo Verde, Canada, Chile, China, Costa Rica, Croatia, Czechia, Denmark, Dominican Republic, Egypt, El Salvador, Eswatini, Ethiopia, France, Georgia, Germany, Ghana, Gibraltar, Greece, Hong Kong, Hungary, India Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic of, Kosovo, Kuwait, Kyrgyzstan, Lebanon, Libya, Lithuania, Malaysia, Mayotte, Mexico, Moldova, Republic of, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Nigeria, North Macedonia, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, Romania, Russian Federation, San Marino, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Province of China, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom of Great Britain and Northern Ireland, Viet Nam, and Zimbabwe.
Verify if the analyzer restarts properly after shutdown by attempting multiple restarts. If it fails to reach Ready mode, it may need adjustment.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Worldwide Distribution: US (nationwide) and OUS (foreign) to countries of: Albania, Algeria, Argentina, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bosnia and Herzegovina, Botswana, Brazil, Bulgaria, Cabo Verde,…” 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 published this recall 49 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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-1025-2026 (November 26, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1025-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 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.