Class 2 Device Recall IsMumps IgG

• Date Initiated by Firm: October 20, 2014
• Create Date: May 16, 2016
• Recall Status: Terminated on December 14, 2016
• Recall Number: Z-1685-2016
• Recall Event ID: 73694
• 510(K)Number: K991274
• Product Classification: Enzyme linked immunoabsorbent assay, mumps virus - Product Code LJY
• Product: Diamedix Is-Mumps IgG Test Kit Diamedix Is-Mumps IgG Test Kit is an EIA procedure intended for the qualitative and semi-quantitative detection of Mumps IgG antibodies as an aid in the diagnosis of Mumps infection.
• Code Information: Lot # 20804, Catalog # 720-540. Expiration Date August 31, 2015
• Recalling Firm/ Manufacturer: Diamedix Corporation; 14100 Nw 57th Ct; Miami Lakes FL 33014-3107
• For Additional Information Contact: Tracy T Chadwrick; 305-748-2780
• Manufacturer Reason for Recall: A gel-like substance was found in kit component, sample diluent , that could potentially compromise product performance.
• FDA Determined Cause: Unknown/Undetermined by firm
• Action: The firm, Diamedix, sent letters dated October 14, October 20 and December 5, 2014 to its customers directly informing them of the correction action. Notification of all domestic customers via Certified Mail. Notification fo the international customers via Federal Express and/or e-mail. With the letter, a replacement bottle of Sample B Diluent was sent and the customer was advised to discard any unused bottles of affected product. New lot number labels were provided to identify kits with the replacement Sample B Diluent. Customers with questions were told they could contact Diamedix Technical Services (1-800-327-4565) if they had any questions or required any additional guidance regarding the correction.
• Quantity in Commerce: 697 kits
• Distribution: Worldwide distribution: US nationwide including states of: AZ, CA, CO, FL, GA, IL, IN, KY, MA, MI, MO, NC, NE, NH, NJ, NY, OH, OK, OR, PA, RI, TN, TX, VA, WI and Puerto Rico. and Country of: ITALY.
• 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