Company: Diasorin, Inc
Date of Enforcement Report: 4/20/05
Class: III
PRODUCT
Data reduction program software written specifically for Bio-Tek Elx800 (DiaSorin part # 15713) automated microtiter plate reader with use of Diastat Anti-Thyroglobulin Assay (manufacturer part #7700). Recall # Z-0675-05.
REASON
The data reduction program written for a specific automated microtiter plate reader (Bio-Tek Elx800) was found to be faulty. This program is used to calculate the cut off values for the Diastat Anti-Thyroglobulin Kit assay. The negative Control Upper Limit should be less than 0.95, rather than less than 1.0.
CODE
Software version 9 thru 12.
RECALLING FIRM/MANUFACTURER
Diasorin, Inc., Stillwater, MN, by letter on April 12, 2004. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
6.
DISTRIBUTION
CA, FL, MA, NY, and TX.
