Z-1845-2011

CellQuest Pro SW, version 4.0.2. and later; Becton Dickinson, San Jose, CA 95131 CellQuest Pro software...

Name: Z-1845-2011 CellQuest Pro SW, version 4.0.2. and later; Becton Dickinson, San Jose, CA 95131 CellQuest Pro software...
Creator: BD Biosciences, Systems & Reagents
Published: 2007-09-07
License: https://open.fda.gov/license/

Becton, Dickinson and Company, BD Biosciences / initiated 2007-09-07 / Terminated / root cause: software

FDA source

BD Biosciences, Systems & Reagents began a recall of 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... on 2007-09-07. The reason FDA records is "Results and gates could be mismatched if you utilize the undo function to undo a gate that was deleted". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1845-2011
Status: Terminated
Initiated: 2007-09-07
Posted: 2011-03-30
Terminated: 2011-03-31
Recalling firm: Becton, Dickinson and Company, BD Biosciences
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.
Product code: GKZ Counter, Differential Cell
Reason for recall: Results and gates could be mismatched if you utilize the undo function to undo a gate that was deleted.
Root cause tag: software
FDA root cause: Software design
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.
Quantity in commerce: 4552
Distribution: Worldwide Distribution
Product codes and lots: Catalog numbers: 343926, 339455, 343928, 347527, and 347526.

Product code GKZ

K946055Class IITritest Reagent Cd3 Fitc/cd4 Pe/cd45 PercpBecton Dickinson Immunocytometry Systems / cleared 1996-02-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)