Company: Beckman Coulter, Inc.
Date of Enforcement Report: 9/15/04
Class: II

PRODUCT
COULTER LH 500 Hematology Analyzer part numbers: 178832, 178833, and 178834 software versions 1A and 1A2. The LH 500 Analyzer is a quantitative, automated hematology analyzer and leukocyte differential cell counter For In Vitro Diagnostic Use in clinical laboratories. The LH %500 Analyzer also provides a semi-automated reticulocyte analysis. Recall # Z-1433-04.

REASON
Beckman Coulter has confirmed an issue associated with the predilute mode of the COULTER LH 500 Hematology Analyzer. The workstation may display, transmit, and/or print an erroneous result or an incorrect dilution factor with a predilute sample result.

CODE
Software versions 1A and 1A2.

RECALLING FIRM/MANUFACTURER
Beckman Coulter, Inc., Brea, CA, by letter, dated August 12, 2004. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
222 units.

DISTRIBUTION
Nationwide and Canada.