Company: Diasorin, Inc
Date of Enforcement Report: 4/20/05
Class: III

PRODUCT
Data reduction program written for a specific automated microtiter plate instrument (Bio-Tek Elx800 reader) for use with Diastat Anti-Beta2 Glycoprotein ELISA assay kit. Recall # Z-0674-05.

REASON
The data reduction program written for a specific automated microtiter plate instrument (Bio-Tek Elx800 reader) is faulty in that the positive result limit is to be greater than 15 U/ml, rather than greater than or equal to 15 U/ml.

CODE
Software version 12.

RECALLING FIRM/MANUFACTURER
Diasorin, Inc., Stillwater, MN, by letter on October 26, 2004. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
7.

DISTRIBUTION
CT, MI, MT, UT, and Canada.