Recall Z-2397-2012 ยท GKZ Counter, Differential Cell
BD Biosciences, Systems & Reagents
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.
| Date | Sep 17, 2012 (initiated Jun 29, 2012) |
| Status | Terminated |
| Reason | Incorrect version of the CD was included with BD FACS 7 Color Setup Beads. |
| 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 occu |
| Quantity | 96 kits |
| Distribution | Worldwide Distribution -- USA (nationwide) including the countries of Australia, Belgium, Canada, Chile, Korea, Mexico, Singapore and Taiwan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K040026 | BD FACS 7-COLOR SETUP BEADS Becton Dickinson Immunocytometry Systems, Sep 10, 2004 |