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Leica Biosystems Richmond Inc. recalls Cell Marque, Microphthalmia Transcription Factor (MiTF) (C5/D5 Mab.), 7 mL, REF PA0803, IVD, The antibody is intended
Recalled September 20, 2017 · FDA recall Z-3122-2017 · 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
10
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, Microphthalmia Transcription Factor (MiTF) (C5/D5 Mab.), 7 mL, REF PA0803, IVD, The antibody is intended for in vitro diagnostic (IVD) use. The Microphthalmia Transcription Factor (MiTF) (C5/D5) antibody is intended for qualified laboratories to qualitatively identify by light microscopy the presence of associated antigens in sections of formalin-fixed, paraffin-embedded tissue sections using IHC test methods.
Manufacturer(s)
Leica Biosystems Richmond Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →