FDAOctober 20, 2014device
Diamedix Is-EBV-VCA 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.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
A gel-like substance was found in kit component, sample diluent , that could potentially compromise product performance.
What to do
FDA enforcement status: Terminated
Brands named
diamedix
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDADiamedix Is-Mumps IgG Enzyme Immunoassay Test Kit for In Vitro Diagnostic Use Catalog No. 720-5402018-01-05
- FDADiamedix Is-EBV-EA-D IgG Enzyme Immunoassay Test Kit for In Vitro Diagnostic Use Catalog No. 720-6402018-01-05
- FDADiamedix Is-CMV IgG Test Kit2015-03-26
- FDADiamedix Is-Mumps 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.2014-10-20
- FDADiamedix 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.2014-10-20
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