Z-2397-2012Class II

BD FACS 7-color Setup beads BD Biosciences, San Jose, CA 95131. BD FACS 7 color Setup Beads are for in vitro...

Name: Z-2397-2012 BD FACS 7-color Setup beads BD Biosciences, San Jose, CA 95131. BD FACS 7 color Setup Beads are for in vitro...
Creator: BD Biosciences, Systems & Reagents
Published: 2012-06-29
License: https://open.fda.gov/license/

Becton, Dickinson and Company, BD Biosciences / initiated 2012-06-29 / Terminated / root cause: manufacturing process

FDA source

BD Biosciences, Systems & Reagents began a recall of BD FACS 7-color Setup beads BD Biosciences, San Jose, CA 95131. BD FACS 7 color Setup Beads are for in vitro diagnostic use on BD FACSCanto or BD FACSCanto II... on 2012-06-29. FDA classified it as Class II and gives the reason as "Incorrect version of the CD was included with BD FACS 7 Color Setup Beads". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2397-2012
Classification: Class II
Status: Terminated
Initiated: 2012-06-29
Posted: 2012-09-17
Terminated: 2013-03-25
Recalling firm: Becton, Dickinson and Company, BD Biosciences
Product: BD FACS 7-color Setup beads BD Biosciences, San Jose, CA 95131. BD FACS 7 color Setup Beads are for in vitro diagnostic use on BD FACSCanto or BD FACSCanto II systems. The beads are run with BD FACSCanto clinical software. This system provides application specific setup, including automated compensation and cytometer quality control (QC) with minimal user intervention.
Product code: GKZ Counter, Differential Cell
Reason for recall: Incorrect version of the CD was included with BD FACS 7 Color Setup Beads.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: BD Biosciences sent a Important Product Recall Information letter beginning July 3, 2012, to all affected consignees via Fed Express. The letter identified the product the problem and the action needed to be taken by the customer. The customers were informed that the CD enclosed in their recent purchase of BD FACS 7-Color Setup Beads, lot number 33412, contain CD version 2.0 instead of the newer version 3.0. The letter goes on to explain the the potential risk and include a table of listed range values to determine if a potential false pass or false fail for the listed detectors has occurred. Customers are asked to check the CD with the kit to ensure that it is version 3.0 (the kit lot number ID is on the CD label). If it is not the correct version, discard version 2.0 and do not use it with this bead kit. Call BAD customers service for a replacement. If the 2.0 kit was already uses, letters request that clinicians inspect the FITC and APC-CY7 stains in the plots of the laboratory reports for the clinical applications in BD FACSCanto clinical software for compromised resolution between negative and dim populations. The verification form/effectiveness check should be completed and returned as requested. Questions or concerns may be directed to BD Customer Support at 1-855-236-2772.
Quantity in commerce: 96 kits
Distribution: Worldwide Distribution -- USA (nationwide) including the countries of Australia, Belgium, Canada, Chile, Korea, Mexico, Singapore and Taiwan.
Product codes and lots: Catalog number: 335775; Lot number 33412.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2397-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2397-2012	Class II	Terminated	Voluntary: Firm initiated	2012-09-26	2012-09-17

Product code GKZ

K040026Class IIBd Facs 7-Color Setup BeadsBecton Dickinson Immunocytometry Systems / cleared 2004-09-10

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)