FDAFDA · Food and drugs·Recall number 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 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.
Published September 26, 2012 · Recall initiated: June 29, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Incorrect version of the CD was included with BD FACS 7 Color Setup Beads.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- BD Biosciences, Systems & Reagents
- Distributor
- Worldwide Distribution -- USA (nationwide) including the countries of Australia, Belgium, Canada, Chile, Korea, Mexico, Singapore and Taiwan.
- Lot
- Catalog number: 335775; Lot number 33412.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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