Home / Recalls / Diamedix Corporation / Z-0445-2013

Z-0445-2013 Class II Terminated

Recalled by Diamedix Corporation — Miami, FL

Recall Details

Product Type
Devices
Report Date
December 5, 2012
Initiation Date
August 6, 2012
Termination Date
August 8, 2014
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
65 Test Kits

Product 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 for Recall

Diamedix Corporation recalled their Is-anti-Sm Test Kit due to the Positive Control recovering high out of specification.

Distribution Pattern

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

Code Information

Catalog # 720-240, Lot # T0401, Expiration Date: November 18. 2012

Other recalls by Diamedix Corporation

  • Z-2573-2018 Class III — Diamedix Is-Mumps IgG Enzyme Immunoassay Test Kit for In Vitro Diagnostic Use Ca (January 5, 2018)
  • Z-2574-2018 Class III — Diamedix Is-EBV-EA-D IgG Enzyme Immunoassay Test Kit for In Vitro Diagnostic Use (January 5, 2018)
  • Z-1689-2016 Class II — Diamedix Is-CMV IgG Test Kit (March 26, 2015)
  • Z-1687-2016 Class II — Diamedix Is-EBV-EA-D IgG Test Kit Diamedix Is-Mumps IgG Test Kit is an EIA p (October 20, 2014)
  • Z-1686-2016 Class II — Diamedix Is-EBV-VCA IgG Test Kit Diamedix Is-Mumps IgG Test Kit is an EIA pr (October 20, 2014)
  • Z-1685-2016 Class II — Diamedix Is-Mumps IgG Test Kit Diamedix Is-Mumps IgG Test Kit is an EIA proc (October 20, 2014)