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U.S. Department of Health and Human Services

Enforcement Report - Week of December 5, 2012

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Event Detail

Event ID 63410
Product Type Devices
Status Ongoing
Recalling Firm Diamedix Corporation
City Miami
State FL
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-08-06
Initial Firm Notification of
Consignee or Public
Distribution Pattern 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

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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. Catalog # 720-240, Lot # T0401, Expiration Date: November 18. 2012 Class II Diamedix Corporation recalled their Is-anti-Sm Test Kit due to the Positive Control recovering high out of specification. 65 Test Kits Z-0445-2013