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FDAFDA · Food and drugs·Recall number Z-3124-2017

Cell Marque, Napsin A (MRQ-60 Mab.), 7 mL, REF PA0805, IVD, The antibody is intended for in vitro diagnostic (IVD) use. Napsin A (MRQ-60) Mouse Monoclonal Primary Antibody is intended for laboratory use in the detection of the Napsin A protein in formalin-fixed, paraffin-embedded tissue stained in qualitative immunohistochemistry (IHC) testing.

Published September 20, 2017 · Recall initiated: July 14, 2017

Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

A delay in transit may have contributed to nonconformity as the product was stored outside of defined shipping and handling temperature requirements.

What to do

Voluntary: Firm initiated · E-Mail

Recall details

Manufacturer
Leica Biosystems Richmond Inc.
Distributor
Nationwide Distribution to AR, AZ, CA, CT, FL, GA, IL, IN, KY, LA, MI, MN, NC, NH, NV, NY, OR, PA, SC, TN, TX, VA, and WI.
Lot
Product Code PA0805, Lot No. 46349, Exp. Date 06/11/2019
Risk classification
Class II
Area (FDA)
device
Country
United States

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