Recall Z-1525-2008 ยท GKZ Counter, Differential Cell
BD Biosciences
FACSDiva Software Versions 4.0.1 to 5.0.2, Flow Cytometry Acquisition & Analysis software. Catalog number 641609 Flexible data acquistion and analysis package specifically designed for digital-based flow cytometers.
| Date | Aug 16, 2008 (initiated Apr 5, 2007) |
| Status | Terminated |
| Reason | When data file containing one or no fluoresence parameters is exported, the software will automatically apply compensation to this file and all subsequently exported files. |
| Root cause | Software design |
| Action | The firm has issued a customer Important Product Information letter via mail on 04/20/2007 to inform them of the software issues. The letter states that to avoid this problem, make sure each tube or well has at least two fluorescence parameters before exporting FCS 3.0 data files. Manually exporting tubes or wells one at a time or restarting the software after the export of an FCS data file containing one or no fluorescence parameters will prevent the problem from occurring. Customers are requested to fill out and return the response form and to contact BD Customer Support Center if there a |
| Quantity | 1074 units |
| Distribution | Worldwide Distribution --- USA including states of NY, NM, MI, GA, MD, MA, AL, CA, VA, NC, OH, TX, CO, NJ, PA, MI, CT, IA, MO, NV, KY, IL, TN, FL, MN, FL, UT, WA, OK, CT, WI, SD, AZ, and IN, and countries of Buenos Aires, BE, Brazil, Canada, Chile, China, Hong Kong, Japan, Singapore, Taiwan, Venezue |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K062087 | BD FACSCANTO II FLOW CYTOMETER, MODEL 338960; (5-3), MODEL 339473; (4-2-2), MODEL 338962 Bd Biosciences, Sep 14, 2006 |