FDADecember 19, 2014device
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.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
One lot of CD8 PE is contaminated with CD4 FITC and may cause an unexpected staining pattern and incorrect patient data.
What to do
FDA enforcement status: Terminated
Brands named
bd biosciences systems reagents
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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