Company:Leica Microsystems
Date of Enforcement Report 4/1/2009
Class:ll
PRODUCT
QCA and iQCA software, a video microscopy software system for quantitative estrogen receptor immunohistochemistry; Cell Analysis Inc., Evanston, IL 60201 or Highland Park, IL 60035. Intended to measure and quantitate the percentage and intensity of positively stained nuclei in formalin-fixed, paraffin-embedded tissue specimens immunohistochemically stained for estrogen receptors. Indicated for use as an aid in the management, prognosis and prediction of therapy outcomes of breast cancer when used with reagents validated for those indications, Recall # Z-1040-2009
REASON
A change in the software to open up the software architecture to include other analytes other than Estrogen Receptor was made without FDA review and approval.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Leica Microsystems, Inc., Bannockburn , IL , by letters dated November 6, 2008.
Manufacturer: Vision Biosystems, Mount Waverley , Australia . Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
5 units
DISTRIBUTION
Nationwide
