Medical device recalls Moderate risk

Becton, Dickinson and Company, BD Biosciences recalls CD79b PE (ASR) , Catalog number 335816 ; Hematology: The CD79b antibody recognizes an epitope on the extracellular doma…

Recall date
September 21, 2016
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0128-2017
FDA classification
Class II
Brand / firm
Becton, Dickinson and Company, BD Biosciences
Sold / distributed
Nationwide Distribution to CA, MN, OH and TX.

Why it was recalled

CD79b (SN8) PE is contaminated with a FITC conjugate of unknown antigenic specificity

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

CD79b PE (ASR) , Catalog number 335816 ; Hematology: The CD79b antibody recognizes an epitope on the extracellular domain of a 3640 kilodalton (kDa) type I membrane glycoprotein. Immunoglobulin (Ig) antigen receptors are composed of a non-covalently associated complex of Ig and two other proteins, Iga and Igb, which have been designated as CD79a and CD79b, respectively. antigen

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