UniCel DxI 800 and 600 Access Immunoassay Systems, UniCel DxC 880i, 860i, 660i, and 680i SYNCHRON Access Clinical System
FDA device recall Z-0856-2010 · posted 2010-02-25 · Terminated
Recall details
- Recalling firm
- Beckman Coulter Inc.
- Reason for recall
- This recall was initiated because of software issue was identified in System Software 4.2 and 4.2.1, which may result in the incorrect handling of a wash arm dispense plate motion failure. Instead of generating a red warning event and stopping sample processing, the system will post a yellow caution event and continue to operate with the dispense plate in an elevated position until the instrument
- Action taken
- Beckman Coulter issued an "Urgent: Product Corrective Action" letter dated October 28, 2009. Customers were notified of the affected product and how the issue will be resolved. For further information, contact Beckman Coulter Inc. Technical Support at 1-800-854-3633.
- Root cause
- Software design
- Status
- Terminated
- Product code
- JJE
- Quantity affected
- 377 Instruments
- Distribution
- Worldwide Distribution -- United States and Canada.
- Date initiated
- 2009-10-28
- Date posted
- 2010-02-25
- Date terminated
- 2012-05-07
- 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 DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM (K060256) | Beckman Coulter, Inc. | 2006-02-27 |
| UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM, MODEL 973100 (K023764) | Beckman Coulter, Inc. | 2003-01-28 |