Alinity m 09N15-095Recalls & reported problems
Abbott Molecular Inc. · Alinity m HR HPV AMP Kit · Class 3
All models of Alinity m (13)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
1 FDA recall record name this device's identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Recalls naming this device
- Sep 12, 2024Open, Classified
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. Certain invalidated positive assay controls can be traced to iron leaching into the Alinity m Lysis Solution from the lysis transfer pump in the Alinity m System.
Z-0233-2025 · Root cause: Device Design · Recall details · FDA record ↗
Other KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS devices
- BD COR™ GX INSTRUMENT 443990Becton, Dickinson And Company · KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS1 recall22 reports
- BD COR™ PX INSTRUMENT 443988Becton, Dickinson And Company · KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS1 recall4 reports
- BD Onclarity™ HPV Assay Reagent Pack 441990Becton, Dickinson And Company · KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS8 reports
- BD Onclarity™ HPV SurePath™ Diluent Tubes 445329Becton, Dickinson And Company · KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS3 reports
- BD Onclarity™ HPV Assay Reagent Pack 444075Becton, Dickinson And Company · KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS2 reports
- cobas HPV 09040544190Roche Molecular Systems, Inc. · KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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