Company: Diasorin, Inc
Date of Enforcement Report: 4/20/05
Class: III
PRODUCT
Data reduction program written specifically for Bio-Tek Elx800 automated microtiter plate reader with use of Diastat Anti-Mitochondrial Antibody Kit. Recall # Z-0673-05.
REASON
The data reduction program written for a specific automated microtiter plate instrument (Bio-Tek Elx800 reader) was found to be faulty. This program is used to calculate the cut off values for Diastat Anti-Mitochondrial Antibody Kit. Program should include a borderline specification to indicate repeat testing is needed.
CODE
Software version 12.
RECALLING FIRM
Diasorin, Inc., Stillwater, MN, by letter on April 12, 2004. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
8.
DISTRIBUTION
CA, CT, KS, MA, and WA.