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U.S. Department of Health and Human Services

Class 2 Device Recall Diamedix IsCMV IgG Test Kit

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  Class 2 Device Recall Diamedix IsCMV IgG Test Kit see related information
Date Initiated by Firm March 26, 2015
Create Date May 17, 2016
Recall Status1 Terminated 3 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/
Diamedix Corporation
14100 Nw 57th Ct
Miami Lakes FL 33014-3107
For Additional Information Contact Yamile Athanasaw
Manufacturer Reason
for Recall
Product contained an incorrect substrate.
FDA Determined
Cause 2
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.