DxI 800 Access Immunoassay Analyzer W/Dual Gantry recall: Software Issue
DxI 800 Access Immunoassay Analyzer W/Dual Gantry, Part Number A71457
Why was DxI 800 Access Immunoassay Analyzer W/Dual Gantry 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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI-DI: 15099590369231; Serial Numbers: 608109
- Product
- DxI 800 Access Immunoassay Analyzer W/Dual Gantry, Part Number A71457
- Recalling firm
- Beckman Coulter, Inc.
- Quantity
- 1 system
- Distribution
- Worldwide distribution - US Nationwide.
- Recall date
- August 13, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)