Class II — Becton Dickinson & Co.
| Recalling firm | Becton Dickinson and Company |
|---|---|
| Registered facility | View this company's 36 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Increased levels of false positives in BD Probe Tech Neisseria gonorrhoeae Q Amplified DNA assay kits. |
| 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. |
| Quantity | 77 kits |
| Distribution | Distributed in the states of CA, FL, GA, NJ, and TX. |
| Initiated | 2013-02-08 |
| Classified | 2013-05-03 |
| Terminated | 2013-05-13 |
| Recall number | Z-1215-2013 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Becton Dickinson & Co. (Z-1215-2013).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/64444/
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