Devices

Device Recall BD ProbeTec Neisseria gonorrhoeae (GC) Qx Amplified DNA Assay Reagent Pack

Model / Serial
Lot No./Exp. Date: 2237214 / 2013-10-31.
Product Classification
Immunology and Microbiology Devices
Device Class
2
Implanted device?
No
Distribution
Distributed in the states of CA, FL, GA, NJ, and TX.
Product Description
BD ProbeTec Neisseria gonorrhoeae (GC) Qx Amplified DNA Assay Reagent Pack, REF 441124, contains 12 each Microwells labeled in part ***BD ProbeTec Neisseria gonorrhoeae (GC) Qx Amplified DNA Assay Reagent Pack REF 441124 ***For use with the BD Viper System *** Becton, Dickinson and Company 7 Loveton Circle, Sparks, MD 21152 USA www.bd.com/ds EC REP Benex Limited, Pottery Road, Dun Laoghaire, Co. Dublin, Ireland. || Assay is indicated for use with asymptomatic and symptomatic individuals to aid in the diagnosis of gonococcal urogenital disease.
Manufacturer
Becton Dickinson & Co.
1 Event
- Recall of Device Recall BD ProbeTec Neisseria gonorrhoeae (GC) Qx Amplified DNA Assay Reagent Pack

Manufacturer

Becton Dickinson & Co.

Manufacturer Address
Becton Dickinson & Co., BD Diagnostic Systems, 7 Loveton Circle, Sparks MD 21152-0999
Manufacturer Parent Company (2017)
Becton, Dickinson and Company
Source
USFDA

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