Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System
Microbiology · 21 CFR 866.3975
A vaginitis and bacterial vaginosis nucleic acid detection system is a qualitative in vitro diagnostic device for the direct detection of nucleic acid sequences from microorganisms associated with vaginitis or bacterial vaginosis. The device is indicated for individuals with signs and symptoms of vaginitis or bacterial vaginosis and aids in the diagnosis of these vaginal infections.
Recent MDR events
26 adverse event reports on file
- APTIMA CV/TV ASSAYMar 12, 2026InjuryHologic, Inc.2024800-2026-00010
- APTIMA CV/TV ASSAYFeb 25, 2026InjuryHologic, Inc.2024800-2026-00008
- APTIMA CV/TV ASSAYAug 13, 2025InjuryHologic, Inc.2024800-2025-00052
- APTIMA CV/TV ASSAYFeb 6, 2025InjuryHologic, Inc.2024800-2025-00007
- BD MOLECULAR SWAB COLLECTION KITJan 8, 2025InjuryGeneohm Sciences Canada, Inc. (bd Diagnostics)3007420875-2025-00011
- BD MOLECULAR SWAB COLLECTION KITSep 19, 2024MalfunctionBecton, Dickinson And Company20255814
- MOLECULAR SWAB COLLECTION KITAug 12, 2024MalfunctionBd / Geneohm Sciences Canada, Ulc.MW5158365
- BD MAX¿ VAGINAL PANELJun 7, 2024MalfunctionGeneohm Sciences Canada, Inc. (bd Diagnostics)3007420875-2024-00056
- BD MAX¿ VAGINAL PANELApr 1, 2024MalfunctionGeneohm Sciences Canada, Inc. (bd Diagnostics)3007420875-2024-00025
- APTIMA CV/TV ASSAYJan 5, 2024InjuryHologic, Inc.2024800-2024-00001
Event type breakdown
Recalls
3 recall events for this product code
- Becton Dickinson & Co.TerminatedUnknown
BD Max Instrument Reader Spare Part, Catalog Number 8090369/443364, 44336409 (Repaired Reader spare part) - Product Usage: The BD MAX System, used in conjuncti
A trend for false positive Candida glabrata results has been confirmed. The discrepant results impact the Candida glabrata target only, when in the presence of a Trichomonas vaginalis true positive.
Z-0312-2019 · View FDA record ↗ - Becton Dickinson & Co.TerminatedUnknown
BD Max Instrument, Catalog Number 441916 441927 (refurbished instrument) - Product Usage: The BD MAX System, used in conjunction with appropriate extraction ki
A trend for false positive Candida glabrata results has been confirmed. The discrepant results impact the Candida glabrata target only, when in the presence of a Trichomonas vaginalis true positive.
Z-0313-2019 · View FDA record ↗ - Becton Dickinson & Co.TerminatedUnknown
Kit BD Max Vaginal Panel;
The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly.
Z-2336-2019 · View FDA record ↗
Registered firms
19 firms currently registered for this product code
510(k) clearances
12 clearances for this product code
- Roche Molecular Systems, Inc.Jul 16, 2026
K260021 · cobas® BV/CV
- Becton, Dickinson and CompanyDec 19, 2024
K243725 · BD Vaginal Panel
- Hologic, Inc.Nov 25, 2024
K243345 · Aptima BV Assay; Aptima CV/TV Assay
- CepheidOct 19, 2023
K231381 · Xpert Xpress MVP; GeneXpert Xpress System
- Becton, Dickinson and CompanyMar 6, 2023
K223653 · BD Vaginal Panel
- CepheidJun 7, 2022
K221160 · Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity System
- CepheidFeb 9, 2022
K212213 · Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity System
- Geneohm Sciences Canada, Inc. (Bd Life Sciences)Oct 18, 2021
K201017 · BD MAX Vaginal Panel, BD MAX System, BD Molecular Swab Collection Kit