Medical device recalls Moderate risk

Leica Microsystems, Inc. recalls Novocastra Liquid Mouse Monoclonal Antibody Calretinin, NCL-L-CALRET-566. Intended for the qualitative identification b…

Recall date
March 22, 2016
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1704-2016
FDA classification
Class II
Brand / firm
Leica Microsystems, Inc.
Sold / distributed
Worldwide Distribution -- U.S., to the following states: AK, CA, FL, GA, MN, MT, NJ, OH, TX and WA; and, the country of Canada.

Why it was recalled

Novocastra Liquid Mouse Monoclonal Antibody Calretinin when used in combination with specific Lots of antibody diluent will give reduced staining.

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

What was recalled

Novocastra Liquid Mouse Monoclonal Antibody Calretinin, NCL-L-CALRET-566. Intended for the qualitative identification by light microscopy of human calretinin molecule in paraffin sections.

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