FDA Device recall Z-0445-2013
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 det…
- FDA Device
- Class II
- terminated
- Published 2012-12-05
On 2012-12-05 the FDA classified a Class II recall of 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 det… by Diamedix, citing diamedix Corporation recalled their Is-anti-Sm Test Kit due to the Positive Control recovering high out of specification.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0445-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-08-06 |
| Published | 2012-12-05 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Diamedix |
| Distribution | US |
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
Diamedix Corporation recalled their Is-anti-Sm Test Kit due to the Positive Control recovering high out of specification.
Identifiers
| code_info | Catalog # 720-240, Lot # T0401, Expiration Date: November 18. 2012 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0445-2013%22
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