FDA-Device2015-11-04Class III
BD CD3 (SK7) FITC; IVD; Catalog # 349201 and 340542 Hematology: The CD3 antibody reacts with the epsilon chain of the CD3 antigen/T-cell antigen receptor (TCR) complex. In vitro diagnostic.
Becton, Dickinson and Company, BD Biosciences
Hazard
Two lots of CD3 (SK7) FITC label contains an error in the Spanish Small text.
Sold states
US (nationwide) Distribution to the states of : TX, GA, IN, TN, CA, KY, WA, IL, MO, NY, CT, MN, NV, KS, WI, NH, FL, PA, OH, OR, SC. OK, NC and LA., and Internationally to Mexico.
Affected count
120 units
Manufactured in
2350 Qume Dr, N/A, San Jose, CA, United States
Products
BD CD3 (SK7) FITC; IVD; Catalog # 349201 and 340542 Hematology: The CD3 antibody reacts with the epsilon chain of the CD3 antigen/T-cell antigen receptor (TCR) complex. In vitro diagnostic.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0171-2016Don't want to check this manually?
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