Cytomics FC 500 MPL Flow Cytometry System with CXP Software, Software Version 2.2, Automated differential cell counter,
FDA device recall Z-0959-2008 · posted 2008-04-30 · Terminated
Recall details
- Recalling firm
- Beckman Coulter Inc
- Reason for recall
- Data generation error: If the cytosettings is not refreshed or restarted during data importation, the output will include old and new data.
- Action taken
- Consignees were notified by an Urgent Product Corrective Action letter sent on 6/29/07. The letter provided details on the data error and instruction on how to avoid the error. Users were asked to retain notification as part of the Quality Systems documentation and return a response form acknowledging receipt. For additional information, contact 1-800-526-7694.
- Root cause
- Software design
- Status
- Terminated
- Product code
- GKZ
- Quantity affected
- 516 units in the US; 73 units in Canada
- Distribution
- Worldwide Distribution- USA and country of Canada.
- Date initiated
- 2007-06-29
- Date posted
- 2008-04-30
- Date terminated
- 2012-12-13
- 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 |
|---|---|---|
| TETRACXP SYSTEM (SOFTWARE AND SYSTEM GUIDE) (K030828) | Beckman Coulter, Inc. | 2003-05-21 |