Home / Recalls / BD Biosciences, Systems & Reagents / Z-1000-2015

Z-1000-2015 Class II Terminated

Recalled by BD Biosciences, Systems & Reagents — San Jose, CA

Recall Details

Product Type: Devices
Report Date: January 28, 2015
Initiation Date: December 19, 2014
Termination Date: February 23, 2016
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 165 units

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.

Distribution Pattern

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.

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