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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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.
Brand
BD Biosciences, Systems & Reagents
Lot Codes / Batch Numbers
Catalog numbers: 343926, 339455, 343928, 347527, and 347526.
Products Sold
Catalog numbers: 343926, 339455, 343928, 347527, and 347526.
BD Biosciences, Systems & Reagents is recalling CellQuest Pro SW, version 4.0.2. and later; Becton Dickinson, San Jose, CA 95131 CellQuest Pro soft due to Results and gates could be mismatched if you utilize the undo function to undo a gate that was deleted.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Results and gates could be mismatched if you utilize the undo function to undo a gate that was deleted.
Recommended Action
Per FDA guidance
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-analyzed. If customers need more information they should contact the Customer Support Center at 877-232-8995.
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 noticePage updated: Jan 10, 2026