FDA Device recall Z-1215-2013
BD ProbeTec Neisseria gonorrhoeae (GC) Qx Amplified DNA Assay Reagent Pack, REF 441124, contains 12 each Microwells labeled in part ***BD P…
- FDA Device
- Class II
- terminated
- Published 2013-05-15
On 2013-05-15 the FDA classified a Class II recall of BD ProbeTec Neisseria gonorrhoeae (GC) Qx Amplified DNA Assay Reagent Pack, REF 441124, contains 12 each Microwells labeled in part ***BD P… by Becton Dickinson And, citing increased levels of false positives in BD Probe Tech Neisseria gonorrhoeae Q Amplified DNA assay kits.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1215-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-02-08 |
| Published | 2013-05-15 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Becton Dickinson And |
| Distribution | CA, FL, GA, NJ, TX |
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.
Reason
Increased levels of false positives in BD Probe Tech Neisseria gonorrhoeae Q Amplified DNA assay kits.
Identifiers
| code_info | Lot No./Exp. Date: 2237214 / 2013-10-31. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1215-2013%22
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