Company:Beckman Coulter, Inc.
Date of Enforcement Report:1/10/2007
Class:ll

PRODUCT
Expo32 ADC Software Version 1.1C, Part Number 6418337-New Users Software Kit, and Part Number 175454 Upgrade Software Kit used with the Coulter EPICS XL Flow Cytometers, Recall # Z-0471-2007

REASON
The firm has confirmed that the ratio parameter assignments (numerator and denominator) of a protocol may inadvertently change after the Parameter Selection Dialog box is accessed. This issue is limited to only protocols utilizing the Ratio parameter.

CODE
Version 1.1C

RECALLING FIRM/MANUFACTURER
Recalling Firm: Beckman Coulter, Inc., Brea, CA, by letter on November 1, 2006.
Manufacturer: Applied Cytometry, Sheffied, UK. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
28 units
DISTRIBUTION
Nationwide