CD8 (Leu-2a) PE (In vitro diagnostic), Catalog number 340046. Hematology: Single color direct ...
FDA Recall #Z-1000-2015 — Class II — December 19, 2014
Product Description
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.
Reason for Recall
One lot of CD8 PE is contaminated with CD4 FITC and may cause an unexpected staining pattern and incorrect patient data.
Recalling Firm
BD Biosciences, Systems & Reagents — San Jose, CA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
165 units
Distribution
Worldwide distribution. US Nationwide including Puerto Rico, China, Brazil, Japan, Guatemala, India, New Zealand, Australia, Canada, Thailand, Chile and Malaysia.
Code Information
Lot number 4220622, Expiry 2016-04-30.
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated