Class 2 Device Recall

• Date Initiated by Firm: August 08, 2005
• Date Posted: February 23, 2006
• Recall Status: Terminated on July 22, 2006
• Recall Number: Z-0557-06
• Recall Event ID: 33128
• 510(K)Number: K991274
• Product Classification: Enzyme Linked Immunoabsorbent Assay, Mumps Virus - Product Code LJY
• 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).
• Code Information: ETI-Mumps Assay software version 1.0
• Recalling Firm/ Manufacturer: Diasorin Inc.; 1951 Northwestern Ave S; Stillwater MN 55082-7536
• For Additional Information Contact: Mary VanTassell; 651-439-9710
• Manufacturer Reason for Recall: 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.
• FDA Determined Cause: Other
• Action: 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.
• Quantity in Commerce: 22
• Distribution: Nationwide. AK, CA, CT, DC, KS, MA, NY, NJ, PA, SD, TN, TX.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = LJY