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U.S. Department of Health and Human Services

Class 2 Device Recall IsEBVVCA IgG

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  Class 2 Device Recall IsEBVVCA IgG see related information
Date Initiated by Firm October 20, 2014
Create Date May 16, 2016
Recall Status1 Terminated 3 on December 14, 2016
Recall Number Z-1686-2016
Recall Event ID 73694
510(K)Number K981812  
Product Classification Epstein-barr virus, other - Product Code LSE
Product Diamedix Is-EBV-VCA 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 # 30804, Catalog # 720-600 Expiration Date April 30, 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 2		 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 588 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 = LSE and Original Applicant = DIAMEDIX CORP.
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