Reported Aug 13, 2025 · Ongoing
DxI 600 Access Immunoassay Analyzer W/Dual Gantry, Part Number A71461
Beckman Coulter, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Beckman Coulter, Inc. · 1000 Lake Hazeltine Dr · Chaska, MN · 55318-1037
Is this the product you have?
- DxI 600 Access Immunoassay Analyzer W/Dual Gantry, Part Number A71461
- Lot codes and dates
- UDI-DI15099590369248
- Serial Numbers902101
- Amount recalled
- 1 system
This recall covers 6 products
The agency filed one notice per product. You are reading one of them; the other 5 are below.
Where it was sold
- Nationwide
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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