Home / Recalls / Medical Devices
Leica Biosystems Richmond Inc. recalls Cell Marque, Podoplanin (D2-40 Mab), 7 mL, REF PA0796, IVD, The antibody is intended for in vitro diagnostic (IVD) us
Recalled September 20, 2017 · FDA recall Z-3120-2017 · 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
4
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, Podoplanin (D2-40 Mab), 7 mL, REF PA0796, IVD, The antibody is intended for in vitro diagnostic (IVD) use. The Podoplanin (D2-40) 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 →