Reported Dec 5, 2012 · Terminated
The Is-anti-Sm test kits****Catalog No: 720-240*** Product Usage: The Diamedix Is-anti-Sm Test Kit is an EIA procedure…
Diamedix Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Diamedix Corporation · 2140 N. Miami Avenue · Miami, FL · 33127
Is this the product you have?
- The Is-anti-Sm test kits****Catalog
- No720-240***
- Product UsageThe 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
- Lot codes and dates
Catalog # 720-240Lot # T0401
- Expiration DateNovember 18. 2012
- Amount recalled
- 65 Test Kits
Where it was sold
Why it was recalled
Diamedix Corporation recalled their Is-anti-Sm Test Kit due to the Positive Control recovering high out of specification.
This product could cause temporary or reversible health problems — stop using it.
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