FDA Device recall Z-2267-2025
DxI 800 Access Immunoassay Analyzer W/Dual Gantry, Part Number A71457
- FDA Device
- Class II
- ongoing
- Published 2025-08-13
On 2025-08-13 the FDA classified a Class II recall of DxI 800 Access Immunoassay Analyzer W/Dual Gantry, Part Number A71457 by Beckman Coulter, citing beckman Coulter has identified that the UniCel DxI 600/800 systems with linear slide PnP gantries running software versions 5.7 and up faced incorrect PnP X-motor current settings….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2267-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-06-25 |
| Published | 2025-08-13 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Beckman Coulter |
| Distribution | US |
Product
DxI 800 Access Immunoassay Analyzer W/Dual Gantry, Part Number A71457
Reason
Beckman Coulter has identified that the UniCel DxI 600/800 systems with linear slide PnP gantries running software versions 5.7 and up faced incorrect PnP X-motor current settings where the PnP X-motor current incorrectly resets to 1.5A (instead of the required 2.0A) because the software overwrites the factory setting during installs or upgrades. This anomaly causes increased PnP motion errors which could lead to delays in reporting patient sample results if unnoticed.
Identifiers
| code_info | UDI-DI: 15099590369231; Serial Numbers: 608109 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2267-2025%22
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