Recall Z-1026-2026 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Beckman Coulter, Inc.
Beckman Coulter UniCel Dxl 800, Part numbers: 973100, A71456, A71457, A25288; Immunoassay Method, Troponin Subunit
| Date | Jan 6, 2026 (initiated Nov 26, 2025) |
| Status | Open, Classified |
| Reason | 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 | Device Design |
| Action | 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 |
| 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, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K121790 | ACCESS ACCUTNI REAGENT, ACCESS ACCUTNI CALIBRATOR, UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM Beckman Coulter, Inc., Sep 25, 2013 |