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Leica Biosystems Richmond Inc. recalls Cell Marque, Glypican-3 (1G12 Mab), 7 mL, REF PA0800, IVD, The antibody is intended for in vitro diagnostic (IVD) use. G
Recalled September 20, 2017 · FDA recall Z-3121-2017 · Leica Biosystems Richmond
Hazard
A delay in transit may have contributed to nonconformity as the product was stored outside of defined shipping and handling temperature requirements. · FDA Class II
Units
3
Sold at
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.
Description
A delay in transit may have contributed to nonconformity as the product was stored outside of defined shipping and handling temperature requirements.
Product
Cell Marque, Glypican-3 (1G12 Mab), 7 mL, REF PA0800, IVD, The antibody is intended for in vitro diagnostic (IVD) use. Glypican-3 (1G12) Mouse Monoclonal Primary Antibody is intended for laboratory use in the detection of the Glypican-3 protein in formalin-fixed, paraffin-embedded tissue stained in qualitative immunohistochemistry (IHC) testing.
Manufacturer(s)
Leica Biosystems Richmond Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →