FDA recall Z-1388-2025

Beckman Coulter, Inc. · Class II · device

Product

DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137.

Reason for recall

the DxI 9000 encoder wheel was misaligned on the motor shaft, leading to increased slippage errors and causing the instrument to stop, posing a high safety risk due to potential delays in patient results.

Distribution

US Nationwide. Global Distribution.

Key facts

Status: Ongoing
Initiation date: 2025-02-05
Report date: 2025-03-26
Voluntary/Mandated: Voluntary: Firm initiated
Location: Chaska, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1388-2025