BD Vaginal Panel on BD COR System 443976Recalls & reported problems
Becton, Dickinson And Company · Kit Vaginal Reagent COR IVD · 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 00382904439767), received between Jun 24, 2025 and Jun 24, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “False Positive 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 Positive Result1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 24, 2025False Positive Result; False Positive Result
IT WAS REPORTED THAT DURING USE OF BD VAGINAL PANEL ON BD COR SYSTEM, A FALSE POSITIVE PATIENT RESULT FOR ALL TARGETS (CANDIDA GROUP, CANDIDA GLABRATA, CANDIDA KRUSEI, AND TRICHOMONAS VAGINALIS) WAS OBTAINED. SAMPLE WAS REPEATED ON BD MAX¿ SYSTEM AND WAS ONLY POSITIVE FOR C. GLABRATA. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22323798 ↗
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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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