Z-1530-2008

BD FACSDiva Software v6.0 and 6.1 with the HP XW4400 Computer System Model/Catalog number 642685 Software is...

Name: Z-1530-2008 BD FACSDiva Software v6.0 and 6.1 with the HP XW4400 Computer System Model/Catalog number 642685 Software is...
Creator: BD Biosciences
Published: 2007-12-21
License: https://open.fda.gov/license/

Becton, Dickinson and Company, BD Biosciences / initiated 2007-12-21 / Terminated / root cause: software

FDA source

BD Biosciences began a recall of BD FACSDiva Software v6.0 and 6.1 with the HP XW4400 Computer System Model/Catalog number 642685 Software is used to simplify acquisition of flow cytometry data on 2007-12-21. The reason FDA records is "Values might not update in statistics views after certain functions are performed in a worksheet". 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-1530-2008
Status: Terminated
Initiated: 2007-12-21
Posted: 2008-08-08
Terminated: 2008-09-24
Recalling firm: Becton, Dickinson and Company, BD Biosciences
Product: BD FACSDiva Software v6.0 and 6.1 with the HP XW4400 Computer System Model/Catalog number 642685 Software is used to simplify acquisition of flow cytometry data.
Product code: GKZ Counter, Differential Cell
Reason for recall: Values might not update in statistics views after certain functions are performed in a worksheet.
Root cause tag: software
FDA root cause: Software design
Action: The firm issued an Important Product Information notification letter on 12/21/2007. The letter instructs users to reload data by closing and reopening an experiment before reporting results in order to determine if their statistics have been impacted. They are asked to fill out and return a form pertaining to this problem. BD Biosciences will release a version of BD FACSDiva software to correct this problem. The letter also stated that BD Biosciences rep will contact the users when the new software is available. User are asked to contact BD Customer Support Center at 1-877-232-8995 if they have any additional questions.
Quantity in commerce: 74 units
Distribution: Nationwide Distribution.
Product codes and lots: Material numbers 338960, 338962, and 339473

Product code GKZ

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)