27
Aug
2009

Cl Il CellTracks AutoPrep System

0

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

About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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