Device product
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.
Z-1215-2013
Product summary
- Event
- Event 64444
- Status
- Terminated
- Classification
- Class II
- Quantity
- 77 kits
- Official record key
device-enforcement:Z-1215-2013
Official wording
Reason: Increased levels of false positives in BD Probe Tech Neisseria gonorrhoeae Q Amplified DNA assay kits.
Code information: Lot No./Exp. Date: 2237214 / 2013-10-31.
Distribution pattern: Distributed in the states of CA, FL, GA, NJ, and TX.
Derived failure modes
-
Unknown
Increased levels of false positives in BD Probe Tech Neisseria gonorrhoeae Q Amplified DNA assay kits.