Device 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.
Z-0445-2013
Product summary
- Event
- Event 63410
- Status
- Terminated
- Classification
- Class II
- Quantity
- 65 Test Kits
- Official record key
device-enforcement:Z-0445-2013
Official wording
Reason: Diamedix Corporation recalled their Is-anti-Sm Test Kit due to the Positive Control recovering high out of specification.
Code information: Catalog # 720-240, Lot # T0401, Expiration Date: November 18. 2012
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
Derived failure modes
-
Potency or specification failure
out of specification