FDA Device recall Z-1546-2024
DxI 9000 Access Immunoassay Analyzer, REF C11137, vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative dete…
- FDA Device
- Class II
- ongoing
- Published 2024-09-11
On 2024-09-11 the FDA classified a Class II recall of DxI 9000 Access Immunoassay Analyzer, REF C11137, vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative dete… by Beckman Coulter, citing beckman Coulter manufacturing discovered cracks around a threaded insert on the bottom of the Internal Wash Buffer Tank that is used within the Wash Buffer Supply Drawer on the Dx….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1546-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-03-05 |
| Published | 2024-09-11 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Beckman Coulter |
| Distribution | US |
Product
DxI 9000 Access Immunoassay Analyzer, REF C11137, vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids.
Reason
Beckman Coulter manufacturing discovered cracks around a threaded insert on the bottom of the Internal Wash Buffer Tank that is used within the Wash Buffer Supply Drawer on the DxI 9000.This can result in leaking, leading to delays in reporting patient test results, exposure to physical and chemical hazards, and damage to equipment or the environment.
Identifiers
| code_info | UDI/DI 15099590732103, Serial Numbers: 300254, 300256, 300257, 300258, 300259, 300263, 300264, 300266, 300268, 300269,…UDI/DI 15099590732103, Serial Numbers: 300254, 300256, 300257, 300258, 300259, 300263, 300264, 300266, 300268, 300269, 300270, 300271, 300272, 300273, 300275, 300281, and 300282 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1546-2024%22
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