Company: Beckman Coulter, Inc.
Date of Enforcement Report: 5/28/03
Class: III

PRODUCT
COULTER PrepPlus and PrepPlus 2, Pipetting and Diluting station for Clinical Use. Recall # Z-0805-03.

REASON
Software problem may cause the instrument to skip the probe-wash step before processing different reagents.

CODE
All existing versions of the software. Serial numbers PrepPlus 0006026440 and above PrepPlus 2 0109079674 and above.

RECALLING FIRM/MANUFACTURER
Beckman Coulter, Inc., Brea, CA, by letter on March 28, 2003. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
98.

DISTRIBUTION
Nationwide and Canada.