Recall Z-0380-06 ยท JJF Analyzer, Chemistry, Micro, For Clinical Use
Beckman Coulter Inc
Cytomics FC500 with CXP Software
| Date | Jan 11, 2006 (initiated Nov 23, 2005) |
| Status | Terminated |
| Reason | Under certain conditions an incorrect Tube ID (Barcode) can be displayed and printed on the Runtime Panel Report in CXP Cytometer Software Version 2.0 |
| Root cause | Software change control |
| Action | A Product Corrective Action letter will be mailed the week of Nov 28, 2005 to all FC500 wi CXP Software customers. Each user will be contacted initially and then once more (if needed) in order to determine the rate of response from the Response form provided. |
| Quantity | 179 |
| 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.