FDA recall Z-1326-2025

Beckman Coulter, Inc. · Class II · device

Product

DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137

Reason for recall

The DxI 9000 Access Immunoassay Analyzer wash wheel mixer may not spin freely within the idler pulley housing. When the problem occurs, the analyzer may generate a system event for a Wash Wheel Dispense Arm Spin Mixer Error that is displayed on the navigation bar in the User Interface. The analyzer enters the red system status and will generate a SYS flag. The tests that are in progress may be cancelled and may cause a delay in reporting patient results

Distribution

US Nationwide. Global Distribution.

Key facts

Status
Ongoing
Initiation date
2024-11-13
Report date
2025-03-19
Voluntary/Mandated
Voluntary: Firm initiated
Location
Chaska, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1326-2025