Beckman Coulter Biomedical GmbH recalls DxA 5000; Catalog Number:B50516; UDI:15099590707118 - Product Usage: The DxA 5000 is a high-speed, modular, automated s…

Recall date

June 17, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2983-2020

FDA classification

Class II

Brand / firm

Beckman Coulter Biomedical GmbH

Sold / distributed

Worldwide distribution - US Nationwide distribution including in the states of Illinois, Ohio, Pennsylvania, and West Virginia. The countries of Australia, Canada, China, Czech Republic, France, Israel, Italy, Germany, Switzerland, Spain, Netherlands, and United Kingdom.

Why it was recalled

The DxA 5000 instructions for use may be confusing regarding the re-use of sample IDs. Beckman Coulter has received complaints where the re-use of sample barcodes were not being detected by the system .

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

DxA 5000; Catalog Number:B50516; UDI:15099590707118 - Product Usage: The DxA 5000 is a high-speed, modular, automated sample handling system that performs pre-analytical and post-analytical sample processing and storage. The automation system also sorts, routes, and presents sample tubes to analyzers for analysis. The DxA 5000 also consolidates a variety of analytical instruments, such as an Immunoassay analyzer, into a unified workstation on a track system.