BD Affirm™ VPIII Microbial Identification Test 446257Recalls & reported problems
Becton, Dickinson And Company · BD Affirm™ VPIII Microbial Identification Test · Class 1
All models of BD Affirm VPIII Microbial Identification Test (2)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This BD Affirm VPIII Microbial Identification Test is a DNA probe test used to identify microbes linked to vaginal infections. All 164 of its adverse event reports are malfunctions, with no injuries and no deaths. Nearly all describe false positive results, with recent reports naming Gardnerella vaginalis. Reports fell from 161 in the prior 12 months to 0 in the last 12 months. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 164
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 164 adverse event reports that list this exact device (DI 00382904462574), received between Nov 16, 2021 and Aug 1, 2025 — classified as 164 malfunctions.
The most frequently reported specific device problem is “False Positive Result” (162 reports).
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 Result162
- False Negative Result2
Patient problems
- No Clinical Signs, Symptoms or Conditions164
Recent adverse event reports
The 25 most recent of 164 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 1, 2025False Positive Result; False Positive Result
IT WAS REPORTED WHILE USING BD AFFIRM¿ VPIII MICROBIAL IDENTIFICATION TEST, THERE WAS A FALSE POSITIVE RESULT FOR GARDNERELLA VAGINALIS. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22686449 ↗MalfunctionJul 30, 2025False Positive Result; False Positive Result
IT WAS REPORTED WHILE USING BD AFFIRM¿ VPIII MICROBIAL IDENTIFICATION TEST, THERE WAS A FALSE POSITIVE RESULT FOR GARDNERELLA VAGINALIS. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22664751 ↗MalfunctionJul 30, 2025False Positive Result; False Positive Result
IT WAS REPORTED WHILE USING BD AFFIRM¿ VPIII MICROBIAL IDENTIFICATION TEST, THERE WAS A FALSE POSITIVE RESULT FOR GARDNERELLA VAGINALIS. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22664750 ↗MalfunctionJul 30, 2025False Positive Result; False Positive Result
IT WAS REPORTED WHILE USING BD AFFIRM¿ VPIII MICROBIAL IDENTIFICATION TEST, THERE WAS A FALSE POSITIVE RESULT FOR GARDNERELLA VAGINALIS. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22664749 ↗MalfunctionJul 30, 2025False Positive Result; False Positive Result
IT WAS REPORTED WHILE USING BD AFFIRM¿ VPIII MICROBIAL IDENTIFICATION TEST, THERE WAS A FALSE POSITIVE RESULT FOR GARDNERELLA VAGINALIS. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22664747 ↗MalfunctionJul 30, 2025False Positive Result; False Positive Result
IT WAS REPORTED WHILE USING BD AFFIRM¿ VPIII MICROBIAL IDENTIFICATION TEST, THERE WAS A FALSE POSITIVE RESULT FOR GARDNERELLA VAGINALIS. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22664734 ↗MalfunctionJul 30, 2025False Positive Result; False Positive Result
IT WAS REPORTED WHILE USING BD AFFIRM¿ VPIII MICROBIAL IDENTIFICATION TEST, THERE WAS A FALSE POSITIVE RESULT FOR GARDNERELLA VAGINALIS. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22664733 ↗MalfunctionJul 30, 2025False Positive Result; False Positive Result
IT WAS REPORTED WHILE USING BD AFFIRM¿ VPIII MICROBIAL IDENTIFICATION TEST, THERE WAS A FALSE POSITIVE RESULT FOR GARDNERELLA VAGINALIS. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22664731 ↗MalfunctionJul 30, 2025False Positive Result; False Positive Result
IT WAS REPORTED WHILE USING BD AFFIRM¿ VPIII MICROBIAL IDENTIFICATION TEST, THERE WAS A FALSE POSITIVE RESULT FOR GARDNERELLA VAGINALIS. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22664730 ↗MalfunctionJul 30, 2025False Positive Result; False Positive Result
IT WAS REPORTED WHILE USING BD AFFIRM¿ VPIII MICROBIAL IDENTIFICATION TEST, THERE WAS A FALSE POSITIVE RESULT FOR GARDNERELLA VAGINALIS. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22664729 ↗MalfunctionJul 30, 2025False Positive Result; False Positive Result
IT WAS REPORTED WHILE USING BD AFFIRM¿ VPIII MICROBIAL IDENTIFICATION TEST, THERE WAS A FALSE POSITIVE RESULT FOR GARDNERELLA VAGINALIS. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22664728 ↗MalfunctionJul 30, 2025False Positive Result; False Positive Result
IT WAS REPORTED WHILE USING BD AFFIRM¿ VPIII MICROBIAL IDENTIFICATION TEST, THERE WAS A FALSE POSITIVE RESULT FOR GARDNERELLA VAGINALIS. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22664727 ↗MalfunctionJul 30, 2025False Positive Result; False Positive Result
IT WAS REPORTED WHILE USING BD AFFIRM¿ VPIII MICROBIAL IDENTIFICATION TEST, THERE WAS A FALSE POSITIVE RESULT FOR GARDNERELLA VAGINALIS. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22664726 ↗MalfunctionJul 30, 2025False Positive Result; False Positive Result
IT WAS REPORTED WHILE USING BD AFFIRM¿ VPIII MICROBIAL IDENTIFICATION TEST, THERE WAS A FALSE POSITIVE RESULT FOR GARDNERELLA VAGINALIS. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22664725 ↗MalfunctionJul 30, 2025False Positive Result; False Positive Result
IT WAS REPORTED WHILE USING BD AFFIRM¿ VPIII MICROBIAL IDENTIFICATION TEST, THERE WAS A FALSE POSITIVE RESULT FOR GARDNERELLA VAGINALIS. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22664724 ↗MalfunctionJul 30, 2025False Positive Result; False Positive Result
IT WAS REPORTED WHILE USING BD AFFIRM¿ VPIII MICROBIAL IDENTIFICATION TEST, THERE WAS A FALSE POSITIVE RESULT FOR GARDNERELLA VAGINALIS. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22664723 ↗MalfunctionJul 30, 2025False Positive Result; False Positive Result
IT WAS REPORTED WHILE USING BD AFFIRM¿ VPIII MICROBIAL IDENTIFICATION TEST, THERE WAS A FALSE POSITIVE RESULT FOR GARDNERELLA VAGINALIS. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22664722 ↗MalfunctionJul 30, 2025False Positive Result; False Positive Result
IT WAS REPORTED WHILE USING BD AFFIRM¿ VPIII MICROBIAL IDENTIFICATION TEST, THERE WAS A FALSE POSITIVE RESULT FOR GARDNERELLA VAGINALIS. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22664717 ↗MalfunctionJul 30, 2025False Positive Result; False Positive Result
IT WAS REPORTED WHILE USING BD AFFIRM¿ VPIII MICROBIAL IDENTIFICATION TEST, THERE WAS A FALSE POSITIVE RESULT FOR GARDNERELLA VAGINALIS. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22664715 ↗MalfunctionJul 30, 2025False Positive Result; False Positive Result
IT WAS REPORTED WHILE USING BD AFFIRM¿ VPIII MICROBIAL IDENTIFICATION TEST, THERE WAS A FALSE POSITIVE RESULT FOR GARDNERELLA VAGINALIS. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22663005 ↗MalfunctionJul 30, 2025False Positive Result; False Positive Result
IT WAS REPORTED WHILE USING BD AFFIRM¿ VPIII MICROBIAL IDENTIFICATION TEST, THERE WAS A FALSE POSITIVE RESULT FOR GARDNERELLA VAGINALIS. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22663000 ↗MalfunctionJul 30, 2025False Positive Result; False Positive Result
IT WAS REPORTED WHILE USING BD AFFIRM¿ VPIII MICROBIAL IDENTIFICATION TEST, THERE WAS A FALSE POSITIVE RESULT FOR GARDNERELLA VAGINALIS. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22662996 ↗MalfunctionJul 30, 2025False Positive Result; False Positive Result
IT WAS REPORTED WHILE USING BD AFFIRM¿ VPIII MICROBIAL IDENTIFICATION TEST, THERE WAS A FALSE POSITIVE RESULT FOR GARDNERELLA VAGINALIS. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22662994 ↗MalfunctionJul 30, 2025False Positive Result; False Positive Result
IT WAS REPORTED WHILE USING BD AFFIRM¿ VPIII MICROBIAL IDENTIFICATION TEST, THERE WAS A FALSE POSITIVE RESULT FOR GARDNERELLA VAGINALIS. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22662993 ↗MalfunctionJul 30, 2025False Positive Result; False Positive Result
IT WAS REPORTED WHILE USING BD AFFIRM¿ VPIII MICROBIAL IDENTIFICATION TEST, THERE WAS A FALSE POSITIVE RESULT FOR GARDNERELLA VAGINALIS. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22662990 ↗
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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