UniCel Dxl 800 Access Immunoassay System Software Versions 2.2.1 and earlier
FDA device recall Z-0583-06 · posted 2006-03-03 · Terminated
Recall details
- Recalling firm
- Beckman Coulter Inc
- Reason for recall
- The UniCel Dxl 800 Access Immunoassay may aspirate a sample from an incorrect rack and generate a result, which is not flagged (under a specific set of circumstances)
- Action taken
- A Product Corrective Action letter will be mailed the week of Feb 06 2006 to all UniCel 800 Dxl customers informing them of a rare condition on the UniCel Dxl 800 Access Immunoassay Systems. Under a specific set of circumstances, the UniCel Dxl 800 may aspirate a sample from an incorrect rack and generate a result, which is not flagged. (Letter is sent by US mail)
- Root cause
- Software design
- Status
- Terminated
- Product code
- JJE
- Quantity affected
- 280 total (263 in US & 17 in Canada)
- Distribution
- Nationwide and Canada
- Date initiated
- 2006-02-06
- Date posted
- 2006-03-03
- Date terminated
- 2012-03-06
- 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 |