Recall Z-0429-2026 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Beckman Coulter, Inc.
Beckman Coulter UniCel DxI 800, Part Numbers: 973100, A71456; Photometric Chemistry Analyzer
| Date | Nov 4, 2025 (initiated Oct 1, 2025) |
| Status | Open, Classified |
| Reason | An internal investigation has determined that due to defective sub-components within the gantry assembly, a z-axis CAD movement motion error may occur and cause an analyzer to enter a Not Ready or Paused state, leading to a delay in obtaining results. |
| Root cause | Process control |
| Action | Beckman Coulter issue an URGENT MEDICAL DEVICE RECALL notice to its consignees on 10/01/2025 via USPS and email. The notice explained the issue, potential impact, and requested the following: If Wash PnP and/or Incubator PnP Z-motion errors appear in the analyzer event log, take the following steps: 1. Attempt to reinitialize the analyzer: a. Go to the Diagnostics screen on the User Interface. b. Select Initialize System. 2. If reinitialization is unsuccessful, contact Beckman Coulter Technical Support in your region. Beckman Coulter recommends posting this letter on or near the affected an |
| Quantity | 657 units |
| Distribution | Worldwide |
| 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 |