FDA Enforcement
Class II
Terminated
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.
Recall: Z-2397-2012
·
Reported September 26, 2012
Enforcement
- Recall Number
- Z-2397-2012
- Event ID
- 62494
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- BD Biosciences, Systems & Reagents
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- September 26, 2012
- Initiation Date
- June 29, 2012
- Classification Date
- September 17, 2012
- Termination Date
- March 25, 2013
- Address
- 2350 Qume Dr, San Jose, CA, 95131-1812, United States
Description
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.
Reason
Incorrect version of the CD was included with BD FACS 7 Color Setup Beads.
Code Info
Catalog number: 335775; Lot number 33412.
Distribution
Worldwide Distribution -- USA (nationwide) including the countries of Australia, Belgium, Canada, Chile, Korea, Mexico, Singapore and Taiwan.
Quantity
96 kits