FDA Medical Device Recalls (openFDA)
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.
- Recall number
- Z-1734-2009
- Recalling firm
- Veridex, LLC
- Product
- 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.
- Status
- Terminated
- Initiated
- 2009-05-06
- Posted
- 2009-08-13
- Terminated
- 2010-10-05
- 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
- Lot, serial or model codes
- CellTracks AutoPrep: 9541, Waste Bottle CT4256.
- 510(k) numbers
- ["K040077"]
- PMA numbers
- not on file
- Product code
- GKH
- Firm FEI
- 3004619490
- Firm city
- Raritan
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28