Z-1215-2013 Class II Terminated
FDA device recall Z-1215-2013 was initiated by Becton Dickinson & Co. on Feb 8, 2013 and is designated Class II. Reason for recall: Increased levels of false positives in BD Probe Tech Neisseria gonorrhoeae Q Amplified DNA assay kits. The recall status is terminated (terminated May 13, 2013). Affected quantity: 77 kits.
Recall Details
- Product Type
- Devices
- Report Date
- May 15, 2013
- Initiation Date
- Feb 8, 2013
- Termination Date
- May 13, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 77 kits
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.
Reason for Recall
Increased levels of false positives in BD Probe Tech Neisseria gonorrhoeae Q Amplified DNA assay kits.
Distribution Pattern
Distributed in the states of CA, FL, GA, NJ, and TX.
Code Information
Lot No./Exp. Date: 2237214 / 2013-10-31.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1215-2013
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026