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BD Biosciences, Systems & Reagents recalls CD8 (Leu-2a) PE (In vitro diagnostic), Catalog number 340046. Hematology: Single color direct immunofluorescence reag
Recalled January 28, 2015 · FDA recall Z-1000-2015 · BD Biosciences, Systems & Reagents
Hazard
One lot of CD8 PE is contaminated with CD4 FITC and may cause an unexpected staining pattern and incorrect patient data. · FDA Class II
Units
165 units
Sold at
Worldwide distribution. US Nationwide including Puerto Rico, China, Brazil, Japan, Guatemala, India, New Zealand, Australia, Canada, Thailand, Chile and Malaysia.
Description
One lot of CD8 PE is contaminated with CD4 FITC and may cause an unexpected staining pattern and incorrect patient data.
Product
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.
Manufacturer(s)
BD Biosciences, Systems & Reagents
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →