Recall Z-1926-2025— Beckman Coulter, Inc.

Name: FDA recall Z-1926-2025
Creator: U.S. Food and Drug Administration
Published: 2025-04-23

Class II · Ongoing

Class II FDA medical device recall by Beckman Coulter, Inc., initiated 2025-04-23. It names one FDA 510(k) clearance: K221225. Product: DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, running software versions 1.20. Reason: A new motor/encoder and cable was introduced into instruments manufactured starting with serial number 300141 incorrectly. This incorrect installation is introducing error codes for the Dxl 9000 which prevents the assay from being performed and a delay in results from being generated, and may require field service to resolve the delay..

Recalling firm: Beckman Coulter, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2025-04-23
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, running software versions 1.20

Reason for recall

A new motor/encoder and cable was introduced into instruments manufactured starting with serial number 300141 incorrectly. This incorrect installation is introducing error codes for the Dxl 9000 which prevents the assay from being performed and a delay in results from being generated, and may require field service to resolve the delay.

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