Z-0570-2008

BD Biosciences MultiSET Flow Cytometry Software Versions 2.1, 2.1.1, and 2.2 with OS X operating systems, BD...

Name: Z-0570-2008 BD Biosciences MultiSET Flow Cytometry Software Versions 2.1, 2.1.1, and 2.2 with OS X operating systems, BD...
Creator: BD Biosciences
Published: 2007-09-06
License: https://open.fda.gov/license/

Becton, Dickinson and Company, BD Biosciences / initiated 2007-09-06 / Terminated / root cause: software

FDA source

BD Biosciences began a recall of BD Biosciences MultiSET Flow Cytometry Software Versions 2.1, 2.1.1, and 2.2 with OS X operating systems, BD Biosciences, San Jose, CA 95131 on 2007-09-06. The reason FDA records is "Inaccurate results: Software error results in inaccurate display result statistics. If the user adjusts the lymph gate or attractors in the Lab Report view without using the Manual Gate function (as described in the...". 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-0570-2008
Status: Terminated
Initiated: 2007-09-06
Posted: 2008-03-04
Terminated: 2008-04-15
Recalling firm: Becton, Dickinson and Company, BD Biosciences
Product: BD Biosciences MultiSET Flow Cytometry Software Versions 2.1, 2.1.1, and 2.2 with OS X operating systems, BD Biosciences, San Jose, CA 95131.
Product code: GKZ Counter, Differential Cell
Reason for recall: Inaccurate results: Software error results in inaccurate display result statistics. If the user adjusts the lymph gate or attractors in the Lab Report view without using the Manual Gate function (as described in the system manual), the statistic results will not be updated to match the adjusted gate.
Root cause tag: software
FDA root cause: Software design
Action: Becton Dickinson sent an Important Product Information letter by mail on 09/14/2007 informing customers of the need to follow the instructions for adjusting the lymph gate or attractors. The next software revision will alleviate this limitation.
Quantity in commerce: 1136 units
Distribution: Worldwide Distribution - USA, Belgium, Brazil, Peru, Singapore, Canada, Jamaica, Chile, Ecuador, Hong Kong-China, Thailand, Mexico, Venezuela, Barbados, Philippines, Puerto Rico, Guatemala, Japan, Uruguay, Argentina, China, Trinidad and Tobago, Honduras, Australia, New Zealand, and India.
Product codes and lots: Software Versions 2.1, 2.1.1, and 2.2 with OS X operating systems.

Product code GKZ

K963963Class IIMultiset Software for Automated Flow Cytometric Data AnalysisBecton Dickinson Immunocytometry Systems / cleared 1996-12-12

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)