DxI 9000 Access Immunoassay Analyzer — Class II medical device recall Z-1546-2024
Ongoing recall by Beckman Coulter, Inc., reported 2024-09-11, distributed nationwide. Beckman Coulter manufacturing discovered cracks around a threaded insert on the bottom of the Internal Wash Bu
| Recall number | Z-1546-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Beckman Coulter, Inc., Chaska, MN, United States |
| Recall initiated | 2024-03-05 |
| Classified | 2024-08-30 |
| Reported by FDA | 2024-09-11 |
| Distributed | Nationwide (US) |
| Countries outside the US | BE, EG, ES, IT, PL |
| Quantity | 17 units |
| Reason classes | chemical contamination, packaging |
| UPC / GTIN / UDI-DI | 15099590732103 |
| Serial numbers | 300254, 300256, 300257, 300258, 300259, 300263, 300264, 300266, 300268, 300269, 300270, 300271, 300272, 300273, 300275, 300281, 300282 |
| Model numbers | C11137 |
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 for recall
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.
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-1546-2024. 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.