Company: ABX Diagnostics, Inc.
Date of Enforcement Report: 9/10/03
Class: II

PRODUCT
ABX Diagnostices Pentra 60C+ Hematology Analyzer. Recall # Z-1149-03.

REASON
Instrument fails to obtain correct patient information/results due to malfunction of the equipment’s sample door.

CODE
Software versions of up to 1.7.

RECALLING FIRM/MANUFACTURER
ABX Diagnostics, Inc., Irvine, CA, by letter on June 5, 2003. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
159.

DISTRIBUTION
Nationwide.