Home / Recalls / Diamedix Corporation / Z-1687-2016

Z-1687-2016 Class II Terminated

Recalled by Diamedix Corporation — Miami Lakes, FL

Recall Details

Product Type
Devices
Report Date
May 25, 2016
Initiation Date
October 20, 2014
Termination Date
December 14, 2016
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
94 kits

Product Description

Diamedix Is-EBV-EA-D IgG Test Kit Diamedix Is-Mumps IgG Test Kit is an EIA procedure intended for the qualitative and semi-quantitative detection of Mumps IgG antibodies as an aid in the diagnosis of Mumps infection.

Reason for Recall

A gel-like substance was found in kit component, sample diluent , that could potentially compromise product performance.

Distribution Pattern

Worldwide distribution: US nationwide including states of: AZ, CA, CO, FL, GA, IL, IN, KY, MA, MI, MO, NC, NE, NH, NJ, NY, OH, OK, OR, PA, RI, TN, TX, VA, WI and Puerto Rico. and Country of: ITALY.

Code Information

Lot # 51104, Catalog # 720-640 Expiration Date August 31, 2015

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-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)
  • Z-0445-2013 Class II — The Is-anti-Sm test kits****Catalog No: 720-240*** Product Usage: The Diamedix (August 6, 2012)