UniCel Dxl 800 Access Immunoassay System, P/N 973100.
FDA device recall Z-0904-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Beckman Coulter Inc
- Reason for recall
- Software coding error may cause a fatal error message.
- Action taken
- Each user will be contacted initially and then once more to ensure that the users have recieved the recall letter and have installed the new software included with the letter. Recall letters were sent March 29, 2003.
- Root cause
- Other
- Status
- Terminated
- Product code
- JJE
- Quantity affected
- 73
- Distribution
- Nationwide and Canada
- Date initiated
- 2004-03-29
- Date posted
- 2004-07-20
- Date terminated
- 2004-09-07
- Location
- Brea, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM, MODEL 973100 (K023764) | Beckman Coulter, Inc. | 2003-01-28 |