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Devices
Device Recall Directigen (TM) EZ RSV
Model / Serial
lots 3253709, exp 12/18/03 and 3289760, exp 2/20/04
Product Classification
Immunology and Microbiology Devices
Device Class
1
Implanted device?
No
Distribution
Product was sold to 242 direct account end users nationwide and 2 affiliated distributors in foreign countries.
Product Description
Directigen (TM) EZ RSV In-Vitro Diagnostic test kit, containing reagents and controls for 30 tests, packaged in papercard carton. Catalog #256030.
Manufacturer
Becton Dickinson & Co.
1 Event
Recall of Device Recall Directigen (TM) EZ RSV
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Manufacturer
Becton Dickinson & Co.
Manufacturer Address
Becton Dickinson & Co., 7 Loveton Cir, Sparks MD 21152-9212
Manufacturer Parent Company (2017)
Becton, Dickinson and Company
Source
USFDA
Language
English
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