Drug recall
Beckman Coulter DxI 9000 Access Immunoassay Analyzer
FDA recall event 96554 · Class II · Beckman Coulter, Inc.
Key facts
| Event ID | 96554 |
|---|---|
| Recall numbers | Z-1664-2025 |
| Recalling firm | Beckman Coulter, Inc. |
| Product type | Devices |
| Products | Beckman Coulter DxI 9000 Access Immunoassay Analyzer |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | When DxI 9000 Access Immunoassay Analyzer is connected to a host system (laboratory information system (LIS) or middleware) and has accumulated canceled QC test results that were not sent by LIS, the… |
| Initiation date | Mar 27, 2025 |
| Report date | Apr 30, 2025 |
| 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: