DxI 800 Access Immunoassay Analyzer W/Spot B, Part Number A71456
Reported: August 13, 2025 Initiated: June 25, 2025 #Z-2268-2025
Product Description
DxI 800 Access Immunoassay Analyzer W/Spot B, Part Number A71456
Reason for Recall
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.
Details
- Recalling Firm
- Beckman Coulter, Inc.
- Units Affected
- 451 systems
- Distribution
- Worldwide distribution - US Nationwide.
- Location
- Chaska, MN
Frequently Asked Questions
What product was recalled? ▼
DxI 800 Access Immunoassay Analyzer W/Spot B, Part Number A71456. Recalled by Beckman Coulter, Inc.. Units affected: 451 systems.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 13, 2025. Severity: Moderate. Recall number: Z-2268-2025.
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