—#217570

Product

Beckman Coulter UniCel Dxl 600, Part numbers: A71460, A71461, A30260; Immunoassay Method, Troponin Subunit

FDA product code: JJE — Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Device class: Class 1
Medical specialty: Clinical Chemistry
510(k) numbers: K121790
Affected lot / code info: A71460: UDI 15099590369224 A71461: UDI 15099590369248 A30260: UDI 15099590341602

Why it was recalled

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.

Root cause (FDA determination)

Device Design

Action the firm took

Beckman Coulter issued an "URGENT MEDICAL DEVICE RECALL" notice dated 11/19/2026 to its consignees on 11/26/2025 via US mail and email. The notice explained the issue, impact, and requested the following actions: -Follow the restart process documented in Section 2 of the "Unicel DxI Access Immunoassay System Instructions for Use." -If your analyzer continues to experience this issue, please contact Beckman Coulter Technical Support. -Beckman Coulter recommends posting this letter on or near the affected analyzers." - Please share this information with your laboratory staff and retain this notification as part of your laboratory Quality System documentation. If you have forwarded any of the affected products listed above to another laboratory, please provide them a copy of this letter." For questions: please contact Customer Support Center: http://www.beckmancoulter.com

Recalling firm

Firm: Beckman Coulter, Inc.
Address: 1000 Lake Hazeltine Dr, Chaska, Minnesota 55318-1037

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2025-11-26
Posted by FDA: 2026-01-06
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #217570. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.