Kit, Dna Detection, Human Papillomavirus
FDA product code MAQ · Class III (high risk) · Microbiology
0510(k) clearances
8PMA approvals
7recalls
PMA approvals
- P230003 Alinity m HR HPV · Abbott Molecular, Inc. · 11/01/2023
- P190028 cobas HPV for use on the cobas 6800/8800 Systems · Roche Molecular Systems, Inc. · 04/03/2020
- P160037 BD Onclarity HPV Assay · Becton, Dickinson and Company · 02/12/2018
- P100020 Cobas HPV Test · Roche Molecular Systems, Inc. · 04/19/2011
- P080015 Cervista HPV 16/18 · Hologic, Inc. · 03/12/2009
- P080014 Cervista HPV HR and Genfind DNA Extraction Kit · Hologic, Inc. · 03/12/2009
- P890064 Viratype Human Papillomavirus DNA Typing Kit · Qiagen Gaithersburg, Inc. · 03/11/1991
- P880009 Virapap Human Papillomavirus DNA Detection Kit · Qiagen, Inc. · 12/23/1988
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0741-2026 Class II | HPV Antigen TestDistribution without premarket approval/clearance. | Get Tested International AB | 11/03/2025Open, Classified |
| Z-2162-2025 Class II | BD COR System Software. Model Number: 444829.Potential for functionality issue that supports the Over labeling feature and could lead to possible false… | Becton Dickinson & Co. | 06/23/2025Open, Classified |
| Z-0587-2025 Class II | BD COR PX Instrument Version or Model: 443988 Catalog Number: 443988BD confirmed that product service credentials used by some BD technical support teams to access certain BD… | Becton Dickinson & Co. | 10/31/2024Open, Classified |
| Z-0233-2025 Class II | Abbott Alinity m HPV AMP Kit, used with the Alinity m System, product codes: a) REF…Abbott has identified an increase of incidences regarding Error Code (EC) 9198 (Positive control is… | Abbott Molecular, Inc. | 09/12/2024Open, Classified |
| Z-0846-2021 Class II | The cobas z 480 analyzer including dedicated software for IVD use is a plate-based…Dirty Lens May Cause Invalid or False Positive Results | Roche Molecular Systems, Inc. | 11/19/2020Terminated |
| Z-3014-2018 Class I | INFORM HPV III Fam 16 Probe - US Export, Catalog Number 05278856001, model 800-4295…Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC… | Ventana Medical Systems Inc | 08/02/2018Terminated |
| Z-2173-2013 Class II | KIT cobas 4800 HPV AMP/DET 240T / 960T US-IVD, CE-IVD Roche Molecular System, Inc. 1080…During an internal investigation, a formulation error that occurred was identified during the manufacture of… | Roche Molecular Systems, Inc. | 07/25/2013Terminated |