Company: Beckman Coulter, Inc
Date of Enforcement Report: 5/19/04
Class: II
PRODUCT
UniCel Dxl 800 Access Immunoassay System, P/N 973100. Recall # Z-0904-04.
REASON
Software coding error may cause a fatal error message.
CODE
All software versions prior to version 1.4.
RECALLING FIRM/MANUFACTURER
Beckman Coulter, Inc., Brea, CA, by letters on March 29, 2004. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
73.
DISTRIBUTION
Nationwide and Canada.