PlainRecalls
FDA Devices Moderate Class II Ongoing

Beckman Coulter UniCel DxI 600, Part Numbers: A71460, A30260; Photometric Chemistry Analyzer

Reported: November 12, 2025 Initiated: October 1, 2025 #Z-0428-2026

Product Description

Beckman Coulter UniCel DxI 600, Part Numbers: A71460, A30260; 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.

Details

Recalling Firm
Beckman Coulter, Inc.
Units Affected
80 units
Distribution
Worldwide
Location
Chaska, MN

Frequently Asked Questions

What product was recalled?
Beckman Coulter UniCel DxI 600, Part Numbers: A71460, A30260; Photometric Chemistry Analyzer. Recalled by Beckman Coulter, Inc.. Units affected: 80 units.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on November 12, 2025. Severity: Moderate. Recall number: Z-0428-2026.