Diamedix Corporation recalls Diamedix Is-EBV-VCA IgG Test Kit Diamedix Is-Mumps IgG Test Kit is an EIA procedure intended for the qualitative and se…

Recall date

October 20, 2014

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1686-2016

FDA classification

Class II

Brand / firm

Diamedix Corporation

Sold / distributed

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.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.