DxA 5000 — Class II medical device recall Z-2983-2020
Terminated recall by Beckman Coulter Biomedical GmbH, reported 2020-09-30, distributed nationwide. The DxA 5000 instructions for use may be confusing regarding the re-use of sample IDs. Beckman Coulter has rec
| Recall number | Z-2983-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Beckman Coulter Biomedical GmbH, Munich, N/A, Germany |
| Recall initiated | 2020-06-17 |
| Classified | 2020-09-18 |
| Reported by FDA | 2020-09-30 |
| Terminated | 2022-08-24 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA, CH, CN, CZ, DE, ES, FR, GB, IL, IT, NL |
| Quantity | 32 units |
| UPC / GTIN / UDI-DI | 15099590707118 |
| Model numbers | B50516 |
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 .
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2983-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.