Company: Diasorin
Date of Enforcement Report:3/12006
Class:lI
PRODUCT
The ETI-Mumps IgG Enzyme Immunoassay Test Kit is sold with assay software version 1.0. that is designed to work exclusively with the ETI-Max 3000 automated platform (version 1.51.1), Recall # Z-0557-06
REASON
Potential for false negative results. A software anomaly may occur when performing the ETI-Mumps IgG assay on the ETI-Max 3000 automated platform. The error occurs when running a combined plate on the ETI-Max 3000, with the ETI-Mumps IgG assay and/or ETI-VZV lgG.
CODE
ETI-Mumps Assay software version 1.0
RECALLING FIRM/MANUFACTURER
Diasorin Inc., Stillwater, MN, by telephone and letter dated August 8, 2005. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
58 kits
DISTRIBUTION
Nationwide
