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Becton, Dickinson and Company, BD Biosciences recalls BD CD64 APC-R700; Analyte Specific Reagent; Model 657701; Lot No. 4344945, 5037611 and 5063945. Hematology - used as
Recalled December 2, 2015 · FDA recall Z-0334-2016 · Becton, Dickinson and Company, BD Biosciences
Hazard
Three lots of CD64 (MD22) are contaminated with CD4 antibody. · FDA Class II
Units
23 vials
Sold at
Distributed in the states of FL, WA, PA, IL, GA, RI, TX, ND, and IA.
Description
Three lots of CD64 (MD22) are contaminated with CD4 antibody.
Product
BD CD64 APC-R700; Analyte Specific Reagent; Model 657701; Lot No. 4344945, 5037611 and 5063945. Hematology - used as analyte specific reagent - contamination leads to possibility of unexpected staining pattern.
Manufacturer(s)
Becton, Dickinson and Company, BD Biosciences
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →