Company: Beckman Coulter, Inc.
Date of Enforcement Report: 8/4/04
Class: III
PRODUCT
DataLink 2000 Data Manager. Version 6.3. Recall # Z-1096-04.
REASON
Software anomaly allows results to be archived prior to validation or to be uploaded to the lab information system.
CODE
Version 6.3
RECALLING FIRM/MANUFACTURER
Beckman Coulter, Inc., Brea, CA, by letter on November 3, 2003. Firm initiated recall is complete.
VOLUME OF PRODUCT IN COMMERCE
361 units.
DISTRIBUTION
Nationwide.
