Recall Z-2271-2025— Beckman Coulter, Inc.

Name: FDA recall Z-2271-2025
Creator: U.S. Food and Drug Administration
Published: 2025-06-25

Class II · Ongoing

Class II FDA medical device recall by Beckman Coulter, Inc., initiated 2025-06-25. It names one FDA 510(k) clearance: K023764. Product: DxI 600 Access Immunoassay Analyzer W/Spot B, Part Number A71460. 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..

Recalling firm: Beckman Coulter, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2025-06-25
Firm location: Chaska, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K023764 — UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM, MODEL 973100Beckman Coulter, Inc.·cleared 2003-01-28

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

DxI 600 Access Immunoassay Analyzer W/Spot B, Part Number A71460

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.