DxI 600 Access Immunoassay Analyzer W/Spot B — Class II medical device recall Z-2271-2025

Ongoing recall by Beckman Coulter, Inc., reported 2025-08-13, distributed nationwide. Beckman Coulter has identified that the UniCel DxI 600/800 systems with linear slide PnP gantries running soft

Recall number	`Z-2271-2025`
Product type	Medical device
Classification	Class II
Status	Ongoing
Voluntary or mandated	Voluntary
Recalling firm	Beckman Coulter, Inc., Chaska, MN, United States
Recall initiated	2025-06-25
Classified	2025-08-05
Reported by FDA	2025-08-13
Distributed	Nationwide (US)
Quantity	177 systems
Reason classes	software
UPC / GTIN / UDI-DI	`15099590369224`
Serial numbers	`901697`, `901890`, `901898`, `902070`, `902075`, `902083`, `902085`, `902089`, `902102`, `902197`, `902204`, `902219`, `902220`, `902222`, `902223`, `902224`, `902225`, `902226`, `902227`, `902228`, `902229`, `902231`, `902244`, `902245`, `902246` and 152 more
Model numbers	`A71460`

Product

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2271-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.