FDA Medical Device Recalls (openFDA)
Diamedix Corporation: 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 number
- Z-0445-2013
- Recalling firm
- Diamedix Corporation
- 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.
- Status
- Terminated
- Initiated
- 2012-08-06
- Posted
- not on file
- Terminated
- 2014-08-08
- Reason
- Diamedix Corporation recalled their Is-anti-Sm Test Kit due to the Positive Control recovering high out of specification.
- Root cause
- Nonconforming Material/Component
- Action
- Diamedix sent a Customer Notification letter to all affected customers via Certified Mail. The letter identifed the affected product. problem and actions to be taken. The letter instructed customers to contact Diamedix Technical Service Department at 1-800-327-4565 or 305-324-2300 to arrange for the return and replacement of any remaining affected product. For questions call 305-324-2314.
- Quantity
- 65 Test Kits
- 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
- Lot, serial or model codes
- Catalog # 720-240, Lot # T0401, Expiration Date: November 18. 2012
- 510(k) numbers
- ["K970220"]
- PMA numbers
- not on file
- Product code
- LLL
- Firm FEI
- 1044713
- Firm city
- Miami
- Firm state
- FL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28