Company: bioMerieux, Inc,
Date of Enforcement Report:4/12/2006
Class:lI
PRODUCT
BacT ALERT Classic 120 System and 240 System, Recall # B-0865-6
REASON
BacT/ALERT Classic Systems, with a software glitch or defect, were distributed.
CODE
All Models
RECALLING FIRM/MANUFACTURER
bioMerieux, Inc., Durham, NC, by letter dated September 17, 2004, firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
3,531 units
DISTRIBUTION
Nationwide and Internationally