Company: Diasorin, Inc
Date of Enforcement Report: 4/20/05
Class: III
PRODUCT
DiaSorin programming software written for a specific automated microtiter plate instrument, Bio-Tek Elx800 reader for use with the ENA 6 Screen ELISA kit assay. Recall # Z-0672-05.
REASON
An error in the Bio-Tek Elx800 microplate reader programming specifications for the ENA screen Assay exists in that an equivocal (borderline) zone is missing.
CODE
Software versions 9 thru 12.
RECALLING FIRM/MANUFACTURER
Diasorin, Inc., Stillwater, MN, by letter on April 20, 2004. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
16.
DISTRIBUTION
CT, FL, NY, WA, TX, AR, TN, and Canada.