Home / Recalls / Diamedix Corporation / Z-2574-2018

Z-2574-2018 Class III Terminated

Recalled by Diamedix Corporation — Miami Lakes, FL

Recall Details

Product Type
Devices
Report Date
August 8, 2018
Initiation Date
January 5, 2018
Termination Date
November 5, 2019
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
147

Product Description

Diamedix Is-EBV-EA-D IgG Enzyme Immunoassay Test Kit for In Vitro Diagnostic Use Catalog No. 720-640

Reason for Recall

Contains a gel-like contaminant that may affect product performance.

Distribution Pattern

AZ, CA, FL, IL, IN, KY, MA, MI, MN, MO, NH, NJ, NY, OH, OK, PA, RI, TN, TX, and WI

Code Information

Lot T0006 Exp. 05/31/2018

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