FDA recall Z-1664-2025

Beckman Coulter, Inc. · Class II · device

Product

Beckman Coulter DxI 9000 Access Immunoassay Analyzer

Reason for recall

When DxI 9000 Access Immunoassay Analyzer is connected to a host system (laboratory information system (LIS) or middleware) and has accumulated canceled QC test results that were not sent by LIS, the analyzer may lose communication with the host system. The lost connection interrupts sample processing, which delays reporting patient test results and may subsequently delay patient treatment.

Distribution

Worldwide distribution.

Key facts

Status
Ongoing
Initiation date
2025-03-27
Report date
2025-04-30
Voluntary/Mandated
Voluntary: Firm initiated
Location
Chaska, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1664-2025