Company: Datascope Corp.
Date of Enforcement Report: 10/5/2005
Class:III

PRODUCT
Elx800 microtiter plate reader software program written for use with ORTHO HCV Version 3.0 ELISA Test System. Recall # Z-1576-05

REASON
An error in the acceptance specification for the substrate blank optical density was discovered in the Bio-Tek Elx800 programming specifications for the ORTHO HCV Version 3.0 ELISA Test System Assay.

CODE
Version 12 and older software

RECALLING FIRM/MANUFACTURER
Recalling Firm: Diasorin Inc., Stillwater, MN, by letters dated March 8, 2004.
Manufacturer: Ortho Clinical Diagnostics, Inc., Raritan, NJ. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
128

DISTRIBUTION
Nationwide