FDA Enforcement
Class II
Terminated
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: Z-0445-2013
·
Reported December 5, 2012
Enforcement
- Recall Number
- Z-0445-2013
- Event ID
- 63410
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Diamedix Corporation
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- December 5, 2012
- Initiation Date
- August 6, 2012
- Classification Date
- November 27, 2012
- Termination Date
- August 8, 2014
- Address
- 2140 N. Miami Avenue, N/A, Miami, FL, 33127, United States
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.
Reason
Diamedix Corporation recalled their Is-anti-Sm Test Kit due to the Positive Control recovering high out of specification.
Code Info
Catalog # 720-240, Lot # T0401, Expiration Date: November 18. 2012
Distribution
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
Quantity
65 Test Kits