DxI 600 Access Immunoassay Analyzer W/Dual Gantry, Part Number A71461
This recall is currently active, issued August 5, 2025. It was issued by Beckman Coulter, Inc..
- Company
- Beckman Coulter, Inc.
- Recall Initiated
- June 25, 2025
- Posted
- August 5, 2025
- Recall Number
- Z-2270-2025
- Quantity
- 1 system
- Firm Location
- Chaska, MN
- Official Source
- View on FDA website ↗
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.
Distribution
Worldwide distribution - US Nationwide.
Lot / Code Info
UDI-DI: 15099590369248; Serial Numbers: 902101
Root Cause
Device Design
Action Taken
An URGENT MEDICAL DEVICE RECALL notification dated 6/25/25 was sent to customers. ACTION: If your laboratory encounters any of the events described in this letter: " Perform a system initialization to resume normal operation. o If repeated initialization attempts fail, contact Customer Technical Support. " Repeat testing for any cancelled tests. " No action is required if your laboratory has not observed the events listed above ESOLUTION: "A Beckman Coulter representative will schedule the modification installation when it is available. 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 product listed above to another laboratory, please provide them a copy of this letter. So that we are assured you have received this important communication, please respond within 10 days in one of the following ways: " Electronically, if you received this communication via email. " Manually, complete and return the enclosed Response Form. If you have any questions regarding this notice, please contact our Customer Support: " From our website: http://www.beckmancoulter.com