Enforcement Report - Week of December 5, 2012
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Product Detail
| Product Description | 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. |
|---|---|
| Recall Number | Z-0445-2013 |
| Classification | Class II |
| Code Info | Catalog # 720-240, Lot # T0401, Expiration Date: November 18. 2012 |
| Product Distributed Qty | 65 Test Kits |
| Reason For Recall | Diamedix Corporation recalled their Is-anti-Sm Test Kit due to the Positive Control recovering high out of specification. |
Event Detail
| Event Id | 63410 |
|---|---|
| Product Type | Devices |
| Status | Ongoing |
| Recalling Firm | Diamedix Corporation |
| City | Miami |
| State | FL | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-08-06 |
| Initial Firm Notification of Consignee or Public | Letter |
| 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 |
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