BD Onclarity™ HPV SurePath™ Diluent Tubes 445329Recalls & reported problems
Becton, Dickinson And Company · Tube HPV LBC Diluent US Surepath 400 ea · Class 3
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 30382904453290), received between Feb 1, 2024 and Feb 6, 2024 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Device Markings/Labelling Problem” (3 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
- Device Markings/Labelling Problem3
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 6, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem
IT WAS REPORTED WHEN USING THE BD ONCLARITY¿ HPV SUREPATH¿ DILUENT TUBES, THE TUBES WERE FOUND TO HAVE AN INCORRECT LABEL MARKING IN EIGHTEEN (18) BOXES. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18652240 ↗MalfunctionFeb 1, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem
IT WAS REPORTED THAT WHEN USING THE BD ONCLARITY¿ HPV SUREPATH¿ DILUENT TUBES, THERE WAS AN INCORRECT LABEL MARKING ON 7 BOXES OF TUBES. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18622770 ↗MalfunctionFeb 1, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem
IT WAS REPORTED WHEN USING THE BD ONCLARITY¿ HPV SUREPATH¿ DILUENT TUBES, THE TUBES WERE FOUND TO HAVE AN INCORRECT LABEL MARKING IN NINE (9) BOXES. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18621749 ↗
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 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 · 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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