Company:Cepheid.
Date of Enforcement Report 6/8/2011
Class ll:
PRODUCT
Xpert Infinity Software, V 4.1a. System software for GeneXpert Infinity 48. Recall # Z-2401-2011
REASON
A mismatch of Patient ID or Sample ID and the Host Order from the hosted LIS and its requested test results could occur when running in batch mode and cartridges are introduced in rapid succession.
RECALLING FIRM/MANUFACTURER
Cepheid, Sunnyvale, CA, by letter dated April 13, 2011. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
19 units
DISTRIBUTION
CA, UT, TX, NJ, FL, NC, CO, IN, VT, MN and the countries of the UK, Denmark and Saudi Arabia
