BD Biosciences, Systems & Reagents recalls CD8 (Leu-2a) PE (In vitro diagnostic), Catalog number 340046. Hematology: Single color direct immunofluorescence reagen…

Recall date

December 19, 2014

Source

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

Recall number

Z-1000-2015

FDA classification

Class II

Brand / firm

BD Biosciences, Systems & Reagents

Sold / distributed

Worldwide distribution. US Nationwide including Puerto Rico, China, Brazil, Japan, Guatemala, India, New Zealand, Australia, Canada, Thailand, Chile and Malaysia.

Why it was recalled

One lot of CD8 PE is contaminated with CD4 FITC and may cause an unexpected staining pattern and incorrect patient data.

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

What was recalled

CD8 (Leu-2a) PE (In vitro diagnostic), Catalog number 340046. Hematology: Single color direct immunofluorescence reagent for enumerating percentages of mature human suppressor/cytotoxic (CD8+) lymphocytes in erythrocyte-lysed whole blood or peripheral blood mononuclear cell suspensions.