Drug recall
DxI 9000 Access Immunoassay Analyzer, C11137; in-vitro diagnostic
FDA recall event 94499 · Class II · Beckman Coulter, Inc.
Key facts
| Event ID | 94499 |
|---|---|
| Recall numbers | Z-2264-2024 |
| Recalling firm | Beckman Coulter, Inc. |
| Product type | Devices |
| Products | DxI 9000 Access Immunoassay Analyzer, C11137; in-vitro diagnostic |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Beckman Coulter is recalling their DxI 9000 Access Immunoassay Analyzers, an in vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte… |
| Initiation date | Apr 18, 2024 |
| Report date | Jul 10, 2024 |
| City | Chaska |
| State | MN |
| Country | United States |
| FEI number | 2122870 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: