Company: Beckman Coulter, Inc.
Date of Enforcement Report: 7/28/04
Class: II
PRODUCT
Synchron Systems Lipid Calibrator (HDLD) Part Number: 650218. Recall # Z-1153-04.
REASON
Incorrect units are printed in labeling but not in software.
CODE
Kit: M302210 Level 1; M302211 Level 2; M302212.
RECALLING FIRM/MANUFACTURER
Beckman Coulter, Inc., Brea, CA, by letters on October 8, 2003. Firm initiated recall is complete.
VOLUME OF PRODUCT IN COMMERCE
2069 kits.
DISTRIBUTION
Nationwide.