Recall Z-0429-2026— Beckman Coulter, Inc.

Name: FDA recall Z-0429-2026
Creator: U.S. Food and Drug Administration
Published: 2025-10-01

Class II · Ongoing

Class II FDA medical device recall by Beckman Coulter, Inc., initiated 2025-10-01. It names one FDA 510(k) clearance: K121790. Product: Beckman Coulter UniCel DxI 800, Part Numbers: 973100, A71456; Photometric Chemistry Analyzer. Reason: 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..

Recalling firm: Beckman Coulter, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2025-10-01
Firm location: Chaska, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K121790 — ACCESS ACCUTNI REAGENT, ACCESS ACCUTNI CALIBRATOR, UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEMBeckman Coulter, Inc.·cleared 2013-09-25

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.