Becton, Dickinson and Company, BD Biosciences recalls BD CD3 (SK7) FITC; IVD; Catalog # 349201 and 340542 Hematology: The CD3 antibody reacts with the epsilon chain of the C…

Recall date

September 30, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0171-2016

FDA classification

Class III

Brand / firm

Becton, Dickinson and Company, BD Biosciences

Sold / distributed

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.

Why it was recalled

Two lots of CD3 (SK7) FITC label contains an error in the Spanish Small text.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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.