Company: Novartis Vaccines and Diagnostic
Date of Enforcement Report 2/13/2008
Class:ll
PRODUCT
Procleix NAT Tracker Version 3.0 Software, Stand Alone Blood, Recall # B-0662-08
REASON
Software, with a glitch or defect, was distributed.
RECALLING FIRM/MANUFACTURER
Novartis Vaccines and Diagnostic, Emeryville, CA, by letter on August 2, 2007 with a follow up letter on August 9, 2007. Firm initiated recall is complete.
VOLUME OF PRODUCT IN COMMERCE
49 units
DISTRIBUTION
Nationwide and Internationally
