Medical device recalls Moderate risk

BD Biosciences, Systems & Reagents recalls Anti-Lambda APC-H7, Catalog Number 656157. Product Usage: Intended for in vitro flow cytometric immunophenotyping of he…

Recall date
December 19, 2014
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1002-2015
FDA classification
Class II
Brand / firm
BD Biosciences, Systems & Reagents
Sold / distributed
US Nationwide Distribution in the states of CA, NY, and MI

Why it was recalled

Two lots of the Anti-Lambda APC-H7 antibody are contaminated with CD38 antibody.

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

What was recalled

Anti-Lambda APC-H7, Catalog Number 656157. Product Usage: Intended for in vitro flow cytometric immunophenotyping of hematologic disorders.

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