Diasorin Inc. Class III

Company: Diasorin Inc.
Date of Enforcement Report: 5/18/05
Class: III

PRODUCT
Programming software (all versions) for Polymedco PolyTiter Immunofluorescent Titration System and used with DiaSorin Anafluor Indirect Fluorescent Antibody Test. Recall # Z-0807-05.

REASON
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.

CODE
All versions of software.

RECALLING FIRM/MANUFACTURER
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).

DISTRIBUTION
Nationwide.

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Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.