FDA Device recall Z-2983-2020
DxA 5000
- FDA Device
- Class II
- terminated
- Published 2020-09-30
On 2020-09-30 the FDA classified a Class II recall of DxA 5000 by Beckman Coulter Biomedical, citing 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 d….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2983-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-06-17 |
| Published | 2020-09-30 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Beckman Coulter Biomedical |
| Distribution | US |
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
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 .
Identifiers
| code_info | Serial/Lot Number(s)/Software Version: all |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2983-2020%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.