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.