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.
This recall has been terminated (originally issued August 16, 2008).
- Company
- Bd Biosciences
- Recall Initiated
- April 5, 2007
- Posted
- August 16, 2008
- Terminated
- September 30, 2009
- Recall Number
- Z-1525-2008
- Quantity
- 1074 units
- Firm Location
- San Jose, CA
- Official Source
- View on FDA website ↗
Reason for Recall
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.
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, Venezuela, Mexico, Trinidad and Tobago, and Columbia.
Lot / Code Info
Software versions 4.0.1 to 5.0.2.
Root Cause
Software design
Action Taken
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 are any additional questions. A software fix is being developed in version 6.0 and a free maintenance release with no product enhancments (version 5.0.3).