Company: Roche Molecular Systems, Inc.
Date of Enforcement Report: 6/11/03
Class: II
PRODUCT
COBAS TaqMan analyzer, Series 96; catalog number 8080216.
Recall # Z-0917-03.
REASON
A false positive result may be reported.
CODE
All units with software versions TaqLink v 1.0 or TaqLink v 1.1.
RECALLING FIRM/MANUFACTURER
Roche Molecular Systems, Inc., Belleville, NJ, by telephone, and letter on March 6, 2003. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
16.
DISTRIBUTION
Nationwide.
