Recall Z-1259-06 ยท LXG Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use
Beckman Coulter Inc
Cytomics FC 500 Flow Cytometry System Part Numbers 626553 (TN; FC500 with UPS), 6605627 (TN; 5 CLR, FC500 (100V)), 6605628 (TN; 5 CLR, FC500 (120V)) , 6605629 (TN; 5 CLR, FC500 (220V)), 6605630 (TN; 5 CLR, FC500 (240V)) with CXP Software Versions 2.0 and 2.1
| Date | Jul 26, 2006 (initiated May 22, 2006) |
| Status | Terminated |
| Reason | Beckman Coulter has determined that under certain conditions a system error generated during a Pause and Rotate routine may result in a sample misidentification with a risk of reporting erroneous results. |
| Root cause | Other |
| Action | A Product Corrective Action letter was sent via US mail the week of May 22, 2006 to all FC500 customers. They were informed that under certain conditions a system error generated during a Pause and Rotate routine may result in a sample misidentification with a risk of reporting erroneous results. The letter includes the sequence in which the issue occurrs: 1) During the acquistion of a tube, the Pause and Rotate Button is selected. 2) A system error is generated during the Pause and Rotate routine (The error message table may be viewed by going to the CXP Help Menu, select the CXP Help Menu |
| Quantity | 424 |
| Distribution | Nationwide and Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.