Company: Cepheid
Date of Enforcement Report: 8/24/05
Class: II

PRODUCT
SmartCycler Diagnostic Software for use with Cepheid brand SmartCycler Real Time PCR Thermocycler, Recall # Z-1378-05

REASON
A problem in the software has the potential to be associated with the incorrect reporting of sample results.

CODE
All units with software code version numbers: PN950-0101, Rev 1.7 and PN950-0108, Rev 1.7a

RECALLING FIRM/MANUFACTURER
Cepheid, Sunnyvale, CA, by letters on July 22, 2005. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
163 units

DISTRIBUTION
Nationwide and Internationally