Recall Z-1026-2026
Beckman Coulter, Inc. · initiated November 26, 2025
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Beckman Coulter UniCel Dxl 800, Part numbers: 973100, A71456, A71457, A25288; Immunoassay Method, Troponin Subunit
Codes / lots: 973100: UDI 15099590265373 (Chaska) and 16954701000412 (Suzhou); A71456: UDI 15099590369194; A71457: UDI 15099590369231; A25288: UDI 15099590194819
Reason for recall
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.
FDA-determined cause: Device Design
Action taken
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
Details
- Recall number
- Z-1026-2026
- Initiated
- November 26, 2025
- Posted by FDA
- January 6, 2026
- Product code
- JJE – Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
- Quantity
- 6457 units
- 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…
- Recalling firm
- Beckman Coulter, Inc., Chaska, MN
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1025-2026 Class II | Beckman Coulter UniCel Dxl 600, Part numbers: A71460, A71461, A30260; Immunoassay…Beckman Coulter has determined that, due to a potential communication issue, the analyzers listed above may… | 11/26/2025Open, Classified |