Home › Device types › MAQ
Kit, Dna Detection, Human Papillomavirus
FDA product code MAQ · Class 3 · Unknown
48
Registered devices
314
Adverse events
12
Recalls
0
510(k) clearances
Devices with this code
cobas HPV — Roche Molecular Systems, Inc.Cervista HTA System — Hologic, Inc.Alinity m — ABBOTT MOLECULAR INC.BD Viper™ LT System PCR Accessory kit — BECTON, DICKINSON AND COMPANYcobas® 4800 System Wash Buffer Kit — Roche Molecular Systems, Inc.Cervista — Hologic, Inc.Alinity m — ABBOTT MOLECULAR INC.BD COR™ PX INSTRUMENT — BECTON, DICKINSON AND COMPANYBD Viper™ LT System PCR Tube/Tray Kit — BECTON, DICKINSON AND COMPANYhc2 HPV DNA Test — QIAGEN SCIENCES INC.BD Onclarity™ HPV Liquid Based Cytology Specimen (LBC) Diluent Tubes — BECTON, DICKINSON AND COMPANYBD Control Set for the BD Onclarity™ HPV Assay — BECTON, DICKINSON AND COMPANYBD Onclarity™ HPV Assay Diluent for BD COR™ — BECTON, DICKINSON AND COMPANYBD Onclarity™ HPV Liquid Based Cytology Specimen (LBC) Diluent Tubes — BECTON, DICKINSON AND COMPANYcobas HPV Positive Control Kit — Roche Molecular Systems, Inc.cobas HPV Positive Control — Roche Molecular Systems, Inc.BD Onclarity™ HPV SurePath™ Diluent Tubes — BECTON, DICKINSON AND COMPANYBD Onclarity™ HPV Extraction Reagent Trough for BD COR™ — BECTON, DICKINSON AND COMPANYcobas® 4800 HPV Amplification/Detection Kit — Roche Molecular Systems, Inc.Cervista — Hologic, Inc.Cervista HTA System — Hologic, Inc.Alinity m — ABBOTT MOLECULAR INC.hc2 High-Risk HPV DNA Test — QIAGEN SCIENCES INC.BD Onclarity™ HPV Assay Reagent Pack — BECTON, DICKINSON AND COMPANY
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-11-03 | GET TESTED INTERNATIONAL AB | Distribution without premarket approval/clearance. |
| 2025-06-23 | Becton Dickinson & Co. | Potential for functionality issue that supports the Over labeling feature and could lead to possible false negative results. |
| 2024-10-31 | Becton Dickinson & Co. | BD confirmed that product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Unti |
| 2024-09-12 | Abbott Molecular, Inc. | Abbott has identified an increase of incidences regarding Error Code (EC) 9198 (Positive control is non-reactive) while using the Alinity m HR HPV AMP Kit and A |
| 2020-11-19 | Roche Molecular Systems, Inc. | Dirty Lens May Cause Invalid or False Positive Results |
| 2018-08-02 | Ventana Medical Systems Inc | Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC result may occur. |
| 2013-07-25 | Roche Molecular Systems, Inc. | During an internal investigation, a formulation error that occurred was identified during the manufacture of the cobas 4800 HPV Master Mix reagent that was pack |
| 2003-10-10 | Beckman Coulter Inc | Labeling Error-Omission of 'Research Use Only' |
| 2003-02-07 | Digene Corp | In Vitro diagnostic test kit may produce false positive patient results |
| 2003-02-07 | Digene Corp | In Vitro diagnostic test kit may produce false positive patient results |
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