BD Affirm VPIII Microbial Identification TestRecalls & reported problems across all models
Becton, Dickinson And Company · 2 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 183
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls
- 0
We found 2 models of BD Affirm VPIII Microbial Identification Test by Becton, Dickinson And Company in the FDA's device registry (GUDID). Together they are named in 183 adverse event reports in the FDA's MAUDE database, received between May 14, 2018 and Sep 19, 2025 — classified as 3 injuries, 180 malfunctions.
The most frequently reported specific device problem is “False Positive Result” (173 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported BD Affirm VPIII Microbial Identification Test problems
Device problems
- False Positive Result173
- False Negative Result4
- Incorrect, Inadequate or Imprecise Result or Readings4
- Adverse Event Without Identified Device or Use Problem1
- Leak/Splash1
Patient problems
- No Clinical Signs, Symptoms or Conditions182
- Exposure to Body Fluids1
- Laceration(s)1
BD Affirm VPIII Microbial Identification Test models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- BD Affirm™ VPIII Microbial Identification Test 446257DNA PROBE, GARDNERELLA VAGINALIS164 reports
- BD Affirm™ VPIII Microbial Identification Test 446252DNA PROBE, TRICHOMONAS VAGINALIS19 reports
Recent BD Affirm VPIII Microbial Identification Test adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 19, 2025False Positive Result; False Positive Result
IT WAS REPORTED THAT DURING USE OF BD AFFIRM¿ VPIII MICROBIAL IDENTIFICATION TEST, A FALSE POSITIVE GARDNERELLA VAGINALIS PATIENT RESULT WAS OBTAINED. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23099947 ↗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 ↗
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Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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