Z-1525-2008

FACSDiva Software Versions 4.0.1 to 5.0.2, Flow Cytometry Acquisition & Analysis software. Catalog number...

Name: Z-1525-2008 FACSDiva Software Versions 4.0.1 to 5.0.2, Flow Cytometry Acquisition & Analysis software. Catalog number...
Creator: BD Biosciences
Published: 2007-04-05
License: https://open.fda.gov/license/

Becton, Dickinson and Company, BD Biosciences / initiated 2007-04-05 / Terminated / root cause: software

FDA source

BD Biosciences began a recall of FACSDiva Software Versions 4.0.1 to 5.0.2, Flow Cytometry Acquisition & Analysis software. Catalog number 641609 Flexible data acquistion and analysis package... on 2007-04-05. The reason FDA records is "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". 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-1525-2008
Status: Terminated
Initiated: 2007-04-05
Posted: 2008-08-16
Terminated: 2009-09-30
Recalling firm: Becton, Dickinson and Company, BD Biosciences
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.
Product code: GKZ Counter, Differential Cell
Reason for recall: 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.
Root cause tag: software
FDA root cause: Software design
Action: 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).
Quantity in commerce: 1074 units
Distribution: Worldwide Distribution --- USA including states of NY, NM, MI, GA, MD, MA, AL, CA, VA, NC, OH, TX, CO, NJ, PA, MI, CT, IA, MO, NV, KY, IL, TN, FL, MN, FL, UT, WA, OK, CT, WI, SD, AZ, and IN, and countries of Buenos Aires, BE, Brazil, Canada, Chile, China, Hong Kong, Japan, Singapore, Taiwan, Venezuela, Mexico, Trinidad and Tobago, and Columbia.
Product codes and lots: Software versions 4.0.1 to 5.0.2.

Product code GKZ

K062087Class IIBd Facscanto II Flow Cytometer, Model 338960; (5-3), Model 339473; (4-2-2), Model 338962Bd Biosciences / cleared 2006-09-14

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)