Company: Radiometer America, Inc.,
Date of Enforcement Report:8/2/2006
Class:lI

PRODUCT
Radiance Data Management System Software Version 2.42 (Stand-alone software package) for the Radiance STAT Analyzer Management System, in vitro diagnostic, Model 914-317 Radiance Basic Kit, Recall # Z-1262-06

REASON
Software anomaly. Data generated by blood gas equipment did not correlate with data shown in the Radiance Data Management System.

CODE
Version 2.42 operating software

RECALLING FIRM/MANUFACTURER
Recalling Firm: Radiometer America, Inc., Westlake, OH, by letters dated March 2, 2005.
Manufacturer: Radiometer A/S, Copenhagen, Denmark. Firm initiated recall is complete

VOLUME OF PRODUCT IN COMMERCE
306 units

DISTRIBUTION
Nationwide