FDAFDA · Food and drugs·Recall number Z-0445-2013
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.
Published December 5, 2012 · Recall initiated: August 6, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Diamedix Corporation recalled their Is-anti-Sm Test Kit due to the Positive Control recovering high out of specification.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Diamedix Corporation
- Distributor
- 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
- Lot
- Catalog # 720-240, Lot # T0401, Expiration Date: November 18. 2012
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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