Diasorin Inc. 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
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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).
Brand
Diasorin Inc.
Lot Codes / Batch Numbers
ETI-Mumps Assay software version 1.0
Products Sold
ETI-Mumps Assay software version 1.0
Diasorin Inc. is recalling The ETI-Mumps IgG Enzyme Immunoassay Test Kit is sold with assay software version 1.0. that is desig due to Potential for false negative results. A software anomaly may occur when performing the ETI-Mumps IgG assay on the ETI-Max 3000 automated platform. Th. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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 as the second assay on a combined plate with ETI-Measles IgG and/or ETI-VZV IgG.
Recommended Action
Per FDA guidance
Consignees were contacted by telephone and then the firm sent a fax titled 'Diasorin Customer Notification' dated 8/8/05 that documented the information as provided by telephone.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026