Recall Z-1388-2025— Beckman Coulter, Inc.

Name: FDA recall Z-1388-2025
Creator: U.S. Food and Drug Administration
Published: 2025-02-05

Class II · Ongoing

Class II FDA medical device recall by Beckman Coulter, Inc., initiated 2025-02-05. It names one FDA 510(k) clearance: K221225. Product: DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137.. Reason: the DxI 9000 encoder wheel was misaligned on the motor shaft, leading to increased slippage errors and causing the instrument to stop, posing a high safety risk due to potential delays in patient results..

Recalling firm: Beckman Coulter, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2025-02-05
Firm location: Chaska, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K221225 — Access TSH (3rd IS) Assay, DxI 9000 Access Immunoassay AnalyzerBeckman Coulter, Inc.·cleared 2022-11-10

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

DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137.

Reason for recall

the DxI 9000 encoder wheel was misaligned on the motor shaft, leading to increased slippage errors and causing the instrument to stop, posing a high safety risk due to potential delays in patient results.

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