# FDA recall Z-2983-2020

> **Beckman Coulter Biomedical GmbH** · Class II · device recall initiated 2020-06-17.

## Product

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.

## 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 .

## Distribution

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.

## Key facts

- **Recall number:** Z-2983-2020
- **Recalling firm:** Beckman Coulter Biomedical GmbH
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-06-17
- **Report date:** 2020-09-30
- **Termination date:** 2022-08-24

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Munich, N/A, Germany

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2983-2020

## Citation

> AI Analytics. FDA recall Z-2983-2020. Retrieved 2026-06-05 from https://api.ai-analytics.org/recall/Z-2983-2020. Source: US FDA. Licensed CC0.

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