Medical device recalls Moderate risk

Leica Microsystems, Inc. recalls Novocastr Liquid Mouse Monoclonal Antibody CDX2 (CDX2) is recommended for the assessment of CDX2 protein in normal and…

Recall date
April 5, 2016
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1877-2016
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 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 CDX2 (CDX2) is recommended for the assessment of CDX2 protein in normal and neoplastic tissues.

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