Devices

Device Recall BD CD8 (SK1) phycoerythrin (PE)

Model / Serial
Lot number 4220622, Expiry 2016-04-30.
Product Classification
Hematology and Pathology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide distribution. US Nationwide including Puerto Rico, China, Brazil, Japan, Guatemala, India, New Zealand, Australia, Canada, Thailand, Chile and Malaysia.
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.
Manufacturer
BD Biosciences, Systems & Reagents
1 Event
- Recall of Device Recall BD CD8 (SK1) phycoerythrin (PE)

Manufacturer

BD Biosciences, Systems & Reagents

Manufacturer Address
BD Biosciences, Systems & Reagents, 2350 Qume Dr, San Jose CA 95131-1812
Manufacturer Parent Company (2017)
Becton, Dickinson and Company
Source
USFDA

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