Beckman Coulter Biomedical GmbH: Medical Device Recall in 2020 - (Recall #: Z-2983-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: June 17, 2020

Date Posted: September 30, 2020

Recall Number: Z-2983-2020

Event ID: 85874

Reason for Recall:

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 .

Status: Terminated

Product Quantity: 32 units

Code Information:

Serial/Lot Number(s)/Software Version: all

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated