cobas HPV 09040544190Recalls & reported problems
Roche Molecular Systems, Inc. · Class 3
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00875197006889), received between Nov 22, 2024 and Nov 22, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “Device Emits Odor” (1 report).
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 Emits Odor1
- Use of Device Problem1
Patient problems
- Aspiration/Inhalation1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 22, 2024Device Emits Odor; Use of Device Problem; Device Emits Odor; Use of Device Problem
THE INITIAL REPORTER ALLEGED THAT DURING THE USE OF THE COBAS 5800 INSTRUMENT EXPERIENCED A CHEMICAL BURN TO THE UPPER RESPIRATORY TRACT. IT WAS ALLEGED TO HAVE OCCURRED DURING AN HPV RUN WHERE A SHARP UNPLEASANT ODOR EMANATED FROM THE DEVICE. THE OPERATOR ALLEGEDLY SOUGHT MEDICAL SUPPORT AND WENT TO THE HOSPITAL AND WAS DIAGNOSED WITH A CHEMICAL BURN OF THE UPPER RESPIRATORY TRACT. IT IS UNKNOWN WHAT KIND OF MEDICAL TREATMENT WAS PROVIDED. ALLEGEDLY, BEFORE THE INCIDENT THE OPERATOR HAD NO HEALTH PROBLEMS. ALTHOUGH MULTIPLE ATTEMPTS WERE MADE, NO ADDITIONAL INFORMATION ON THE OPERATOR'S STATUS COULD BE PROVIDED.
Patient problems: Aspiration/Inhalation
MAUDE report 20762087 ↗
Other KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS devices
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- 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
- BD Onclarity™ HPV Assay Reagent Pack 444075Becton, Dickinson And Company · KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS2 reports
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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