BD Onclarity™ HPV Assay Reagent Pack 444075Recalls & reported problems
Becton, Dickinson And Company · Kit HPV Assay Reagent for BD COR US · Class 3
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00382904440756), received between Jun 7, 2025 and Nov 17, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “False Positive Result” (2 reports).
1 other recall cover devices cleared under the same FDA submission (P160037); they may or may not involve this specific model.
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 18, 2026.
Reports received per month
Most reported problems
Device problems
- False Positive Result2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 17, 2025False Positive Result; False Positive Result
IT WAS REPORTED THAT DURING USE OF BD ONCLARITY¿ HPV ASSAY REAGENT PACK FOR BD COR, AN HPV P3 FALSE POSITIVE PATIENT RESULT WAS OBTAINED. TEST WAS REPEATED ON NEW SAMPLE AND WAS P3 NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23575122 ↗MalfunctionJun 7, 2025False Positive Result; False Positive Result
IT WAS REPORTED THAT DURING USE OF BD ONCLARITY¿ HPV ASSAY REAGENT PACK FOR BD COR, A DISCREPANT PATIENT RESULT WAS OBTAINED. ON 2 DIFFERENT COR RUNS, THE FIRST TEST WAS HPV POSITIVE, AND THE SECOND TEST WAS HPV NEGATIVE. SAMPLE WAS TESTED THE THIRD TIME USING VIPER LT AND GAVE A NEGATIVE RESULT. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22162306 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under P160037. One submission often covers many models, so check the product and lot details in each record.
- Z-2162-2025 · Jun 23, 2025 · Open, ClassifiedBD COR System Software. Model Number: 444829.
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
- Alinity m 09N15-095Abbott Molecular Inc. · KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS1 recall0 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
- 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 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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