Company: bioMerieux, Inc,
Date of Enforcement Report:7/8/2006
Class:lI

PRODUCT
OBSERVA R02 (version R02.00.17) computers using PSC 6000 or HHP Barcode Scanners which are connected to BacT/ALERT 3D. Recall # Z-1161-06

REASON
Software problem with scanner inter-character delay which may result in false positive or false negative results after incorrect scanning of bottle IDs.

CODE
Software version R.02.00.17

RECALLING FIRM/MANUFACTURER
Recalling Firm: bioMerieux, Inc., Hazelwood, MO, by telephone and letters on May 22, 2006.
Manufacturer: bioMerieux, Inc., Durham, NC, firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
51 systems

DISTRIBUTION
Nationwide and Internationally