Home / Recalls / Medical Devices
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 us
Recalled September 30, 2015 · FDA recall Z-2817-2015 · Becton, Dickinson and Company, BD Biosciences
Hazard
CD4 FITC label contains an error in the Spanish small text - it states CD8 FITC. · FDA Class III
Units
128 units
Sold at
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.
Description
CD4 FITC label contains an error in the Spanish small text - it states CD8 FITC.
Product
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).
Manufacturer(s)
Becton, Dickinson and Company, BD Biosciences
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →