Company: Haag-Streit USA Inc.
Date of Enforcement Report 7/27//2010
Class ll:

PRODUCT
UniCel DxI 800 and 600 Access Immunoassay Systems, UniCel DxC 880i, 860i, 660i, and 680i SYNCHRON Access Clinical Systems with DxI System Software versions 4.2 or 4.2.1. In vitro diagnostic device used for the quantitative, semi-quantitive or qualitative determination of various analyte concentrations found in human body fluids. For labeling see UniCel DxI Operator’s Guide. Part Number: 387262G. Recall # Z-0856-2010.

REASON
This recall was initiated because of software issue was identified in System Software 4.2 and 4.2.1, which may result in the incorrect handling of a wash arm dispense plate motion failure. Instead of generating a red warning event and stopping sample processing, the system will post a yellow caution event and continue to operate with the dispense plate in an elevated position until the instrument is reinitialized. Potentially affected results are not flagged.

RECALLING FIRM/MANUFACTURER
Beckman Coulter, Inc., Brea, CA, by letter dated October 28, 2009. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
377 units

DISTRIBUTION
Nationwide and Canada