Recall Z-1734-2009 ยท GKH Apparatus, Automated Blood Cell Diluting
Veridex, LLC
CellTracks AutoPrep System for in vitro diagnostic use, software version 2.2 or greater. Distributed by Veridex, 33 Technology Drive, Warren, NJ 07059. Manufactured by Immunicon, Huntingdon Valley, PA. Immunicon was acquired by Veridex in August of 2008.
| Date | Aug 13, 2009 (initiated May 6, 2009) |
| Status | Terminated |
| Reason | Bottle degradation: Investigation has determined that degradation may occur in the plastic waste bottle of the CellTracks AutoPrep System. |
| Root cause | Device Design |
| Action | Veridex, LLC issued a recall notice to consignees dated March 12, 2009 detailing the affected product. The firm will provide replacement bottles to all customers in the near future. For further questions, contact Veridex Customer Technical Services at 1-877-837-4339. |
| Quantity | 196 instruments |
| Distribution | Worldwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K040077 | IMMUNICON CELLTRACKS AUTOPREP SYSTEM Immunicon Corp., Mar 12, 2004 |