CellTracks AutoPrep System for in vitro diagnostic use, software version 2.2 or greater. Distributed by Veridex, 33 Tech
FDA device recall Z-1734-2009 · posted 2009-08-13 · Terminated
Recall details
- Recalling firm
- Veridex, LLC
- Reason for recall
- Bottle degradation: Investigation has determined that degradation may occur in the plastic waste bottle of the CellTracks AutoPrep System.
- Action taken
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- GKH
- Quantity affected
- 196 instruments
- Distribution
- Worldwide Distribution
- Date initiated
- 2009-05-06
- Date posted
- 2009-08-13
- Date terminated
- 2010-10-05
- Location
- Raritan, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| IMMUNICON CELLTRACKS AUTOPREP SYSTEM (K040077) | Immunicon Corp. | 2004-03-12 |