Company:bioMerieux, Inc.,
Date of Enforcement Report:3/28/2007
Class:ll
PRODUCT
BacT/VIEW C.30a Software update (P/N 514515-1) diagnostic data management system, Recall # Z-0644-2007
REASON
Bottle data is not sent to BacT/ALERT 3D instrument.
CODE
All BacT/ALERT 3D instruments (version C.30a only, not the C.30 version of software).
RECALLING FIRM/MANUFACTURER
bioMerieux, Inc., Durham, NC, by letter on December 20, 2007. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
1233 disks
DISTRIBUTION
Nationwide and Internationally
