Company:Veridex, LLC
Date of Enforcement Report 8/26/2009
Class:ll
PRODUCT
CellTracks AutoPrep System for in vitro diagnostic use, software version 2.2 or greater, Recall # Z-1734-2009
REASON
Bottle degradation: Investigation has determined that degradation may occur in the plastic waste bottle of the CellTracks AutoPrep System.
RECALLING FIRM/MANUFACTURER
Veridex, LLC, Raritan, NJ, by letter dated March 12, 2009. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
196 instruments
DISTRIBUTION
Nationwide and Internationally
