Company: Diasorin, Inc
Date of Enforcement Report: 4/27/05
Class: III

PRODUCT
Version 12 software program written for the Bio- Tek ELx800 automated microtiter plate reader with use of PRO- Trac Tacrolimus ELISA kit. Recall # Z-0702-05.

REASON
The software program written for use in the automated microtiter plate reader (Bio- Tek ELx800) for use with the Pro- Trac II Tacrolimus ELISA kit was found to be faulty. Assay software program did not include the Calibrator Zero OD specification (STDO>=1.500) as specified in the product insert.

CODE
Version 12.

FIRM/MANUFACTURER
Diasorin , Inc., Stillwater , MN , by letters on December 1, 2004 . Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
8 kits.

DISTRIBUTION
CA, DC, FL, KY, and Canada .