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Diamedix Corporation recalls Diamedix Is-EBV-EA-D IgG Test Kit Diamedix Is-Mumps IgG Test Kit is an EIA procedure intended for the qualitative an
Recalled May 25, 2016 · FDA recall Z-1687-2016 · Diamedix
Hazard
A gel-like substance was found in kit component, sample diluent , that could potentially compromise product performance. · FDA Class II
Units
94 kits
Sold at
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.
Description
A gel-like substance was found in kit component, sample diluent , that could potentially compromise product performance.
Product
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.
Manufacturer(s)
Diamedix Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →