Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
The Is-anti-Sm test kits****Catalog No: 720-240*** Product Usage: The Diamedix Recalled by Diamedix Corporation Due to Diamedix Corporation recalled their Is-anti-Sm Test Kit due...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Diamedix Corporation directly.
Affected Products
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.
Quantity: 65 Test Kits
Why Was This Recalled?
Diamedix Corporation recalled their Is-anti-Sm Test Kit due to the Positive Control recovering high out of specification.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Diamedix Corporation
Diamedix Corporation has 7 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report