Recall Z-1530-2008 ยท GKZ Counter, Differential Cell
BD Biosciences
BD FACSDiva Software v6.0 and 6.1 with the HP XW4400 Computer System Model/Catalog number 642685 Software is used to simplify acquisition of flow cytometry data.
| Date | Aug 8, 2008 (initiated Dec 21, 2007) |
| Status | Terminated |
| Reason | Values might not update in statistics views after certain functions are performed in a worksheet. |
| Root cause | Software design |
| Action | The firm issued an Important Product Information notification letter on 12/21/2007. The letter instructs users to reload data by closing and reopening an experiment before reporting results in order to determine if their statistics have been impacted. They are asked to fill out and return a form pertaining to this problem. BD Biosciences will release a version of BD FACSDiva software to correct this problem. The letter also stated that BD Biosciences rep will contact the users when the new software is available. User are asked to contact BD Customer Support Center at 1-877-232-8995 if the |
| Quantity | 74 units |
| Distribution | Nationwide Distribution. |
| FDA record | Open on fda.gov |