Medical device recalls Moderate risk

Leica Microsystems, Inc. recalls BOND Ready-To-Use Primary Antibody CDX2 (EP25), REF PA0375

Recall date
July 30, 2021
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2481-2021
FDA classification
Class II
Brand / firm
Leica Microsystems, Inc.
Sold / distributed
US Nationwide distribution.

Why it was recalled

Product may not perform as specified in IFU.

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

What was recalled

BOND Ready-To-Use Primary Antibody CDX2 (EP25), REF PA0375

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