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U.S. Department of Health and Human Services

Class 2 Device Recall IsantiSm test kit

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  Class 2 Device Recall IsantiSm test kit see related information
Date Initiated by Firm August 06, 2012
Create Date June 26, 2015
Recall Status1 Terminated 3 on August 08, 2014
Recall Number Z-0445-2013
Recall Event ID 63410
510(K)Number K970220  
Product Classification Extractable antinuclear antibody, antigen and control - Product Code LLL
Product The Is-anti-Sm test kits****Catalog No: 720-240***
Product Usage:
The Diamedix Is-anti-Sm Test Kit is an EIA procedure intended for the detection and semi-quantitation of antibodies against the Sm antigen in serum as an aid in the diagnosis of autoimmune disease. The results are reported in ELISA units (EU) per ml determined by comparison to a Calibrator.
Code Information Catalog # 720-240, Lot # T0401, Expiration Date: November 18. 2012
Recalling Firm/
Manufacturer		 Diamedix Corporation
2140 N. Miami Avenue
Miami FL 33127
For Additional Information Contact Glenn Gerstenfeld
305-324-2560
Manufacturer Reason
for Recall		 Diamedix Corporation recalled their Is-anti-Sm Test Kit due to the Positive Control recovering high out of specification.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Diamedix sent a Customer Notification letter to all affected customers via Certified Mail. The letter identifed the affected product. problem and actions to be taken. The letter instructed customers to contact Diamedix Technical Service Department at 1-800-327-4565 or 305-324-2300 to arrange for the return and replacement of any remaining affected product. For questions call 305-324-2314.
Quantity in Commerce 65 Test Kits
Distribution Worldwide Distribution - USA Nationwide including the states: CA, ID, NJ, NY, OH, PA, PR, RI, TN, and TX, FL, and the countries of Italy, Chile and Ecuador
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 = LLL and Original Applicant = DIAMEDIX CORP.
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