FDA recall Z-0429-2026

Beckman Coulter, Inc. · Class II · device

Product

Beckman Coulter UniCel DxI 800, Part Numbers: 973100, A71456; Photometric Chemistry Analyzer

Reason for recall

An internal investigation has determined that due to defective sub-components within the gantry assembly, a z-axis CAD movement motion error may occur and cause an analyzer to enter a Not Ready or Paused state, leading to a delay in obtaining results.

Distribution

Worldwide

Key facts

Status: Ongoing
Initiation date: 2025-10-01
Report date: 2025-11-12
Voluntary/Mandated: Voluntary: Firm initiated
Location: Chaska, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0429-2026