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.
FDA Recall Z-1734-2009 · Posted 2009-08-13
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Recalling FirmVeridex, LLC
Recall StatusTerminated
Product CodeGKH
Date Initiated2009-05-06
Date Terminated2010-10-05
Product Quantity196 instruments
Reason for Recall
Bottle degradation: Investigation has determined that degradation may occur in the plastic waste bottle of the CellTracks AutoPrep System.
Firm 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.
Root Cause
Device Design
Distribution Pattern
Worldwide Distribution
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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