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.
FDA Recall Z-1000-2015 · Posted 2015-01-20
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Recalling FirmBD Biosciences, Systems & Reagents
Recall StatusTerminated
Product CodeGKL
Date Initiated2014-12-19
Date Terminated2016-02-23
Product Quantity165 units
Reason for Recall
One lot of CD8 PE is contaminated with CD4 FITC and may cause an unexpected staining pattern and incorrect patient data.
Firm Action
Recall notification letters were sent to all consignees on December 19, 2014 by certified mail.
Root Cause
Process control
Distribution Pattern
Worldwide distribution. US Nationwide including Puerto Rico, China, Brazil, Japan, Guatemala, India, New Zealand, Australia, Canada, Thailand, Chile and Malaysia.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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