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

Recall date

January 5, 2018

Source

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

Recall number

Z-2574-2018

FDA classification

Class III

Brand / firm

Diamedix Corporation

Sold / distributed

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

Why it was recalled

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

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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