FDA recall, , Moderate risk
Beckman Coulter UniCel DxI 600 and DxI 800 Immunoassay Systems
Beckman Coulter UniCel Dxl 600 and UniCel Dxl 800 analyzers may not restart after a standard shutdown, causing delayed results.
Summary by Recall Canary from the FDA notice
What happened
Beckman Coulter, Inc. of Chaska, Minnesota, is recalling its UniCel Dxl 800 and UniCel Dxl 600 analyzers. The company determined that, due to a potential communication issue, these analyzers may not successfully restart following a standard shutdown, even after multiple attempts.
If this occurs, the instrument cannot complete initialization and transition to Ready mode, and it will not process patient samples, QCs, or calibrators, causing delayed results. The recall began November 26, 2025, and the FDA added it to its Enforcement Report on January 6, 2026.
The recall covers analyzers distributed nationwide in the US and to foreign countries, including Albania, Argentina, Australia, Brazil, Canada, China, France, Germany, India, Japan, Mexico, South Africa, Spain, the United Kingdom, and many others.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
2 products
Affected if its UDI-DI is listed.
A UDI-DI is the device identifier printed with the barcode on the device label.
Beckman Coulter UniCel Dxl 800, Part numbers: 973100, A71456, A71457, A25288; Immunoassay Method, Troponin Subunit
- UDI-DI
- 15099590265373
- 16954701000412
- 15099590369194
- 15099590369231
- 15099590194819
Beckman Coulter UniCel Dxl 600, Part numbers: A71460, A71461, A30260; Immunoassay Method, Troponin Subunit
- UDI-DI
- 15099590369224
- 15099590369248
- 15099590341602
Recall details
- Company began the recall
- Sold in
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.
- Company
- Beckman Coulter, Inc.Chaska, Minnesota
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98070
- Recall numbers
- Z-1025-2026 to Z-1026-2026
All recalls from Beckman Coulter, Inc.
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
