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Diamedix Corporation recalls The Is-anti-Sm test kits****Catalog No: 720-240*** Product Usage: The Diamedix Is-anti-Sm Test Kit is an EIA procedure
Recalled December 5, 2012 · FDA recall Z-0445-2013 · Diamedix
Hazard
Diamedix Corporation recalled their Is-anti-Sm Test Kit due to the Positive Control recovering high out of specification. · FDA Class II
Units
65 Test Kits
Sold at
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
Description
Diamedix Corporation recalled their Is-anti-Sm Test Kit due to the Positive Control recovering high out of specification.
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.
Manufacturer(s)
Diamedix Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →