Class II

Medical Device Recall: DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, with Component PCB, TSI/RSI firmware C29278

Beckman Coulter, Inc. · February 6, 2025

Reason for Recall

Beckman Coulter identified that an issue for DxI 9000 tip stocker interface (TSI) and reagent storage interface (RSI) boards with the firmware version 1.1.0.0 can cause sub-system communication failures. This failure could result in a delay in reporting patient results.

Distribution

Worldwide - US Nationwide distribution in the states of FL, TX, WA.

States Affected

NATIONWIDE

Quantity Affected

80 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-1387-2025

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.