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.
This recall has been terminated (originally issued August 6, 2012).
- Company
- Diamedix Corporation
- Recall Initiated
- August 6, 2012
- Terminated
- August 8, 2014
- Recall Number
- Z-0445-2013
- Quantity
- 65 Test Kits
- Firm Location
- Miami, FL
- Official Source
- View on FDA website ↗
Reason for Recall
Diamedix Corporation recalled their Is-anti-Sm Test Kit due to the Positive Control recovering high out of specification.
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
Lot / Code Info
Catalog # 720-240, Lot # T0401, Expiration Date: November 18. 2012
Root Cause
Nonconforming Material/Component
Action Taken
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.