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
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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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = LLL
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