Device 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.
Z-2397-2012
Product summary
- Event
- Event 62494
- Status
- Terminated
- Classification
- Class II
- Quantity
- 96 kits
- Official record key
device-enforcement:Z-2397-2012
Official wording
Reason: Incorrect version of the CD was included with BD FACS 7 Color Setup Beads.
Code information: Catalog number: 335775; Lot number 33412.
Distribution pattern: Worldwide Distribution -- USA (nationwide) including the countries of Australia, Belgium, Canada, Chile, Korea, Mexico, Singapore and Taiwan.
Derived failure modes
-
Unknown
Incorrect version of the CD was included with BD FACS 7 Color Setup Beads.