Drug recall
DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, running software versions 1.20
FDA recall event 96760 · Class II · Beckman Coulter, Inc.
Key facts
| Event ID | 96760 |
|---|---|
| Recall numbers | Z-1926-2025 |
| Recalling firm | Beckman Coulter, Inc. |
| Product type | Devices |
| Products | DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, running software versions 1.20 |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | A new motor/encoder and cable was introduced into instruments manufactured starting with serial number 300141 incorrectly. This incorrect installation is introducing error codes for the Dxl 9000 which… |
| Initiation date | Apr 23, 2025 |
| Report date | Jun 18, 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: