Recall Z-2414-2024— Beckman Coulter, Inc.

Name: FDA recall Z-2414-2024
Creator: U.S. Food and Drug Administration
Published: 2024-06-04

Class II · Ongoing

Class II FDA medical device recall by Beckman Coulter, Inc., initiated 2024-06-04. It names one FDA 510(k) clearance: K221225. Product: Dxl 9000 Access Immunoassay Analyzer, Catalog #C11137.. Reason: The analyzers were built with nonconforming USB cables made with brass contacts instead of specified gold contacts. Brass contacts may corrode over time, leading to loss of internal instrument communication and delayed patient results..

Recalling firm: Beckman Coulter, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2024-06-04
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

Dxl 9000 Access Immunoassay Analyzer, Catalog #C11137.

Reason for recall

The analyzers were built with nonconforming USB cables made with brass contacts instead of specified gold contacts. Brass contacts may corrode over time, leading to loss of internal instrument communication and delayed patient results.

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