Class 2 Device Recall Diamedix IsCMV IgG Test Kit

• Date Initiated by Firm: March 26, 2015
• Create Date: May 17, 2016
• Recall Status: Terminated on November 14, 2018
• Recall Number: Z-1689-2016
• Recall Event ID: 73194
• 510(K)Number: K981163
• Product Classification: Enzyme linked immunoabsorbent assay, cytomegalovirus - Product Code LFZ
• Product: Diamedix Is-CMV IgG Test Kit
• Code Information: Catalog # 720-320 Lot # 10105 Expiration Date January 31, 2016
• Recalling Firm/ Manufacturer: Diamedix Corporation; 14100 Nw 57th Ct; Miami Lakes FL 33014-3107
• For Additional Information Contact: Yamile Athanasaw; 800-327-4565
• Manufacturer Reason for Recall: Product contained an incorrect substrate.
• FDA Determined Cause: Other
• Action: On March 26, 2015 Erba Diagnostics sent a communication to their clients informing them of the recall and sending t hem a replacement sustrate HRP to replaced the wrong one sent on the kit.
• Quantity in Commerce: 150 kits
• Distribution: AZ, CA, FL, GA, KY, MA, MI, MN, MO, NC, NE, NY, OH, OK, OR, TN, TX, VA, WI and Puerto Rico.
• 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 = LFZ and Original Applicant = DIAMEDIX CORP.