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.
FDA Recall Z-1845-2011 · Posted 2011-03-30
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Recalling FirmBD Biosciences, Systems & Reagents
Recall StatusTerminated
Product CodeGKZ
Date Initiated2007-09-07
Date Terminated2011-03-31
Product Quantity4552
Reason for Recall
Results and gates could be mismatched if you utilize the undo function to undo a gate that was deleted.
Firm Action
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.
Root Cause
Software design
Distribution Pattern
Worldwide Distribution
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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