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Recall Observatory FDA recall evidence

Device 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.

Z-1000-2015

December 19, 2014

Class II

Product summary

Firm
BD Biosciences, Systems & Reagents
Event
Event 70107
Status
Terminated
Classification
Class II
Quantity
165 units
Official record key
device-enforcement:Z-1000-2015

Official wording

Reason: One lot of CD8 PE is contaminated with CD4 FITC and may cause an unexpected staining pattern and incorrect patient data.

Code information: Lot number 4220622, Expiry 2016-04-30.

Distribution pattern: Worldwide distribution. US Nationwide including Puerto Rico, China, Brazil, Japan, Guatemala, India, New Zealand, Australia, Canada, Thailand, Chile and Malaysia.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    One lot of CD8 PE is contaminated with CD4 FITC and may cause an unexpected staining pattern and incorrect patient data.