The Is-anti-Sm test kits****Catalog No: 720-240*** Product Usage: The… — Class II medical device recall Z-0445-2013
Terminated recall by Diamedix Corporation, reported 2012-12-05, distributed nationwide. Diamedix Corporation recalled their Is-anti-Sm Test Kit due to the Positive Control recovering high out of spe
| Recall number | Z-0445-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Diamedix Corporation, Miami, FL, United States |
| Recall initiated | 2012-08-06 |
| Classified | 2012-11-27 |
| Reported by FDA | 2012-12-05 |
| Terminated | 2014-08-08 |
| Distributed | Nationwide (US) |
| Countries outside the US | CL, EC, IT |
| Quantity | 65 test |
| Reason classes | specification failure |
| Lot numbers | T0401 |
| Model numbers | 720-240 |
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.
Reason for recall
Diamedix Corporation recalled their Is-anti-Sm Test Kit due to the Positive Control recovering high out of specification.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0445-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.