Beckman Coulter DxI 9000 Access Immunoassay Analyzer, catalog number C11137; in-vitro diagnostic instrument
FDA device recall Z-1115-2025 · posted 2025-02-06 · Completed
Recall details
- Recalling firm
- Beckman Coulter, Inc.
- Reason for recall
- A software error caused an increase in tray gripper motion errors that causes intermittent hard stops and a delay in patient results.
- Action taken
- A field service engineer was dispatched to the customer site to perform the software update and to replace the PCB TSI-RSI board from 01/03/2024 through 12/26/2024.
- Root cause
- Software design
- Status
- Completed
- Product code
- JJE
- Quantity affected
- 61 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of Australia, Austria, Brazil, Croatia, France, Germany, Hungary, India, Ireland, Italy, New Zealand, Portugal, Slovakia, Spain, Switzerland, T
- Date initiated
- 2024-01-03
- Date posted
- 2025-02-06
- Location
- Chaska, MN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Access TSH (3rd IS) Assay, DxI 9000 Access Immunoassay Analyzer (K221225) | Beckman Coulter, Inc. | 2022-11-10 |