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hc2 High-Risk HPV DNA Test
QIAGEN SCIENCES INC. · Model 1 · UDI-DI 04053228002000
MAQ
Prescription
0
510(k) clearances
314
Adverse events
12
Recalls
12
Facilities
Description
digene® HC2 High-Risk HPV DNA Test (4-Plate Kit)
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. Until these product serv |
| 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 Alinity m STI AMP Kit |
| 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 packaged in four (4) cob |
| 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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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.