Recall Z-0445-2013 ยท LLL Extractable Antinuclear Antibody, Antigen And Control
Diamedix Corporation
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.
| Date | Aug 6, 2012 |
| Status | Terminated |
| Reason | Diamedix Corporation recalled their Is-anti-Sm Test Kit due to the Positive Control recovering high out of specification. |
| Root cause | Nonconforming Material/Component |
| Action | 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. |
| Quantity | 65 Test Kits |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K970220 | IS-ANTI-SM TEST SYSTEM Diamedix Corp., Apr 8, 1997 |