Company: Diasorin Inc.
Date of Enforcement Report: 5/18/05
Programming software (all versions) for Polymedco PolyTiter Immunofluorescent Titration System and used with DiaSorin Anafluor Indirect Fluorescent Antibody Test. Recall # Z-0807-05.
A problem with software for the PolyTiter Immunofluorescent Titration System in that no flags or warnings appear when PolyTiter Calibrator Values are re-entered or changed (including values changed to unacceptable values) after the initial curve has been generated, if the “refresh button” has not been pressed. The graph may appear valid; however erroneous results may occur.
All versions of software.
Recalling Firm: Diasorin Inc., Stillwater, MN, by letter, on September 24, 2004.
Manufacturer: Polymedco, Inc., Cortlandt Manor, NY. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
68 (27-2.7; 14-2.8 and 27-2.8.1 Software Version).