Recall Z-1913-2025— Beckman Coulter, Inc.

Name: FDA recall Z-1913-2025
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 version 1.20. Reason: A new software update (v1.20) 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 version 1.20

Reason for recall

A new software update (v1.20) 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.