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Leica Biosystems Richmond Inc. recalls Cell Marque, MSH6 (44 Mab.), 7 mL, REF PA0804, IVD, The antibody is intended for in vitro diagnostic (IVD) use. MSH6 i
Recalled September 20, 2017 · FDA recall Z-3123-2017 · 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
13
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, MSH6 (44 Mab.), 7 mL, REF PA0804, IVD, The antibody is intended for in vitro diagnostic (IVD) use. MSH6 is a mismatch repair gene which is deficient in a high proportion of patients with microsatellite instability (MSI-H). This finding is associated with the autosomal dominant condition known as Hereditary Non-Polyposis Colon Cancer (HNPCC).
Manufacturer(s)
Leica Biosystems Richmond Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →