Becton, Dickinson and Company, BD Biosciences recalls CD4 (SK3), FITC; Contains CD4 FITC with gelatin and 0.1% sodium Azide. Catalog number 340133 in vitro diagnostic used i…

Recall date

August 27, 2015

Source

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

Recall number

Z-2817-2015

FDA classification

Class III

Brand / firm

Becton, Dickinson and Company, BD Biosciences

Sold / distributed

Worldwide Distribution. US nationwide (TX, CA, NC, OH, SD, PA, CT, UT, MD, TX, GA), Argentina, Taiwan, Australia, Japan, China, New Zealand, Chile and Colombia.

Why it was recalled

CD4 FITC label contains an error in the Spanish small text - it states CD8 FITC.

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

What was recalled

CD4 (SK3), FITC; Contains CD4 FITC with gelatin and 0.1% sodium Azide. Catalog number 340133 in vitro diagnostic used in Hematology: The SK3 monoclonal antibody reacts with human CD4, a 59-kDa cell surface receptor expressed by a majority of thymocytes, a subpopulation of mature T helper cells, and at low levels on monocytes. CD4 is a receptor for the human immunodeficiency virus (HIV).