Devices

Device Recall BBL Crystal Enteric/Nonfermentor (E/NF) Identification System

Model / Serial
Lot. Number - 3224281 / Exp. Date - 2014/06/09 , Lot. Number - 3290379 / Exp. Date - 2014/07/24, Lot. Number - 3224281 / Exp. Date - 2014/06/09
Product Classification
Immunology and Microbiology Devices
Device Class
1
Implanted device?
No
Distribution
Worldwide Distribution - US (nationwide), Australia, Belgium, Canada, Colombia, China, Indonesia, India, Japan, Korea, Mexico, Malaysia, Peru, Philippines, Singapore, Thailand, and Taiwan.
Product Description
BBL CrystaLEAD Enteric/Nonfermentor (E/NF) Identification (ID) System, catalog number 245000. in vitro diagnostic for the identification of aerobic gram-negative bacteria that belong to the family Enterobacteriaceae as well as some of the more frequently isolated glucose fermenting and nonfermenting gram-negative bacilli.
Manufacturer
Becton Dickinson & Co.
1 Event
- Recall of Device Recall BBL Crystal Enteric/Nonfermentor (E/NF) Identification System

Manufacturer

Becton Dickinson & Co.

Manufacturer Address
Becton Dickinson & Co., 7 Loveton Cir, BD Diagnostic Systems, Sparks MD 21152-9212
Manufacturer Parent Company (2017)
Becton, Dickinson and Company
Source
USFDA

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