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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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.
Brand
BD Biosciences
Lot Codes / Batch Numbers
Software versions 4.0.1 to 5.0.2.
Products Sold
Software versions 4.0.1 to 5.0.2.
BD Biosciences is recalling FACSDiva Software Versions 4.0.1 to 5.0.2, Flow Cytometry Acquisition & Analysis software. Catalog due to When data file containing one or no fluoresence parameters is exported, the software will automatically apply compensation to this file and all subseq. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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).
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AL, AZ, CA, CO, CT, FL, GA, IL, IN, IA, KY, MD, MA, MI, MN, MO, NV, NJ, NM, NY, NC, OH, OK, PA, SD, TN, TX, UT, VA, WA, WI
Page updated: Jan 10, 2026