Recall Z-1845-2011 ยท GKZ Counter, Differential Cell
BD Biosciences, Systems & Reagents
CellQuest Pro SW, version 4.0.2. and later; Becton Dickinson, San Jose, CA 95131 CellQuest Pro software allows you to acquire and analyze data from your flow cytometer on a Macintosh computer.
| Date | Mar 30, 2011 (initiated Sep 7, 2007) |
| Status | Terminated |
| Reason | Results and gates could be mismatched if you utilize the undo function to undo a gate that was deleted. |
| Root cause | Software design |
| Action | Important Product Information letters, dated September 2007, were sent the week of 9/14/2001 via Federal Express to all affected customers. The letters identified the affected product along with the reason for recall. The letter states that "as long as customers do not use the Undo function to undo a gate deletion, the software can be used with full functionality." The letter also states that BD will change the issue in the next software version. If customers believe that they may have analyzed sample files by utilizing the Undo function, then it is recommended that the sample files be re- |
| Quantity | 4552 |
| Distribution | Worldwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K946055 | TRITEST REAGENT CD3 FITC/CD4 PE/CD45 PERCP Becton Dickinson Immunocytometry Systems, Feb 20, 1996 |