Z-1734-2009

CellTracks AutoPrep System for in vitro diagnostic use, software version 2.2 or greater. Distributed by...

Name: Z-1734-2009 CellTracks AutoPrep System for in vitro diagnostic use, software version 2.2 or greater. Distributed by...
Creator: Veridex, LLC
Published: 2009-05-06
License: https://open.fda.gov/license/

Veridex, LLC / initiated 2009-05-06 / Terminated / root cause: design

FDA source

Veridex, LLC began a recall of CellTracks AutoPrep System for in vitro diagnostic use, software version 2.2 or greater. Distributed by Veridex, 33 Technology Drive, Warren, NJ 07059... on 2009-05-06. The reason FDA records is "Bottle degradation: Investigation has determined that degradation may occur in the plastic waste bottle of the CellTracks AutoPrep System". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1734-2009
Status: Terminated
Initiated: 2009-05-06
Posted: 2009-08-13
Terminated: 2010-10-05
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.
Product code: GKH Apparatus, Automated Blood Cell Diluting
Reason for recall: Bottle degradation: Investigation has determined that degradation may occur in the plastic waste bottle of the CellTracks AutoPrep System.
Root cause tag: design
FDA 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 in commerce: 196 instruments
Distribution: Worldwide Distribution
Product codes and lots: CellTracks AutoPrep: 9541, Waste Bottle CT4256.

Product code GKH

K040077Class IImmunicon Celltracks Autoprep SystemImmunicon Corp. / cleared 2004-03-12

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)