Leica Microsystems, Inc. recalls Novocastr Liquid Mouse Monoclonal Antibody Renal Cell Carcinoma Marker (RCC) is recommended for use as part of a panel…

Recall date

April 5, 2016

Source

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

Recall number

Z-1876-2016

FDA classification

Class II

Brand / firm

Leica Microsystems, Inc.

Sold / distributed

Distributed in the following states AR, CA, CT, FL, ID, IL, IN, MT, OH, PA, TN and TX, and in Canada.

Why it was recalled

Testing of retained units indicated that Lot numbers of CDX2 and RCC indicated are not stable up to the expiry date on the product labeling.

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

What was recalled

Novocastr Liquid Mouse Monoclonal Antibody Renal Cell Carcinoma Marker (RCC) is recommended for use as part of a panel of antibodies in the definition of tumors of proximal nephrogenic differentiation.