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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