FDA-Device2015-12-02Class II
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.
Becton, Dickinson and Company, BD Biosciences
Hazard
Three lots of CD64 (MD22) are contaminated with CD4 antibody.
Sold states
Distributed in the states of FL, WA, PA, IL, GA, RI, TX, ND, and IA.
Affected count
23 vials
Manufactured in
2350 Qume Dr, N/A, San Jose, CA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0334-2016Don't want to check this manually?
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