Recall Z-1529-2008 ยท GKZ Counter, Differential Cell
Beckman Coulter Inc
Cytomics FC 500 Flow Cytometry System with Data Innovations Instrument Manager, Part Numbers 626553 and 6605628 A system for the qualitative and quantitative measurement of biological and physical properties of cells and other particles.
| Date | Aug 8, 2008 (initiated Aug 20, 2007) |
| Status | Terminated |
| Reason | Labeling provided by two integrated software systems are not clear enough to avoid potential demographic and sample type mismatches under certain conditions. |
| Root cause | Software design |
| Action | A Product Corrective Action (PCA) letter, dated August 16, 2007, informed the customers that the User documentation and Online Help for the FC500 with Data Innovations lnstrument Manager are not clear enough to avoid potential demographic and sample type mismatches under certain conditions. The letter asks the customers to share the information with their laboratory staff and retain the notification as part of their laboratory Quality System documentation. They are also to review all sample identification, demographics, data and results before reporting results out. A response form is includ |
| Quantity | 141 units |
| Distribution | Worldwide Distribution --- including 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 |