Recall Z-0959-2008 ยท GKZ Counter, Differential Cell
Beckman Coulter Inc
Cytomics FC 500 MPL Flow Cytometry System with CXP Software, Software Version 2.2, Automated differential cell counter, Part Number 626553, Beckman Coulter, Fullerton, CA 92834
| Date | Apr 30, 2008 (initiated Jun 29, 2007) |
| Status | Terminated |
| Reason | Data generation error: If the cytosettings is not refreshed or restarted during data importation, the output will include old and new data. |
| Root cause | Software design |
| Action | 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. |
| Quantity | 516 units in the US; 73 units in Canada |
| Distribution | Worldwide Distribution- USA and country of Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K030828 | TETRACXP SYSTEM (SOFTWARE AND SYSTEM GUIDE) Beckman Coulter, Inc., May 21, 2003 |