Company:Beckman Coulter, Inc
Date of Enforcement Report: 4/9/03
Class: III
PRODUCT
LH 700 Series Hematology Analyzers. Part numbers 66056032, 6605633, 6605645. Recall # Z-0669-03.
CODE
REASON
Incorrect Hemoglobin result can be reported at software version 2A and higher.
All instruments with version 2A or higher.
RECALLING FIRM/MANUFACTURER
Beckman Coulter, Inc., Brea, CA, by telephone and letters from January 27, 2003 to February 3, 2003. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
234.
DISTRIBUTION
Nationwide and Canada.
