Visby Medical Sexual Health Test PS-001402Recalls & reported problems
Visby Medical, Inc. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00810031720064), received between Jul 1, 2025 and Jul 1, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “False Negative Result” (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
- False Negative Result1
Patient problems
- Sexually Transmitted Infection1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 1, 2025False Negative Result; False Negative Result
CUSTOMER REPORTED A DISCREPANT RESULT FOR A PATIENT'S CHLAMYDIA STATUS. THE VISBY MEDICAL SEXUAL HEALTH TEST WAS INTERPRETED AS NEGATIVE FOR CHLAMYDIA. THE RESULTS FROM AN ADDITIONAL TEST WERE POSITIVE FOR CHLAMYDIA. THE VAGINAL SAMPLES FOR THE TWO TESTS WERE COLLECTED BY THE PATIENT ON THE SAME DAY. A THIRD TEST WAS NOT PERFORMED.
Patient problems: Sexually Transmitted Infection
MAUDE report 22374060 ↗
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- BD ProbeTec™ Chlamydia trachomatis (CT) Qx Amplified DNA Assay 441126Becton, Dickinson And Company · DNA-REAGENTS, NEISSERIA5 reports
- Aptima Combo 2® KIT,APTIMACOMBO2,100T,REF,CEIVD-UPDATEDHologic, Inc. · DNA-REAGENTS, NEISSERIA3 reports
- BD Viper™ System 441091Becton, Dickinson And Company · DNA-REAGENTS, NEISSERIA3 reports
- Aptima® APTIMA VAGINAL SWAB COLLECTION KITHologic, Inc. · DNA-REAGENTS, NEISSERIA2 reports
- BD Viper™ System Remanufactured 442843Becton, Dickinson And Company · DNA-REAGENTS, NEISSERIA2 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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