BD MAX™ Vaginal Panel 443712Recalls & reported problems
Becton, Dickinson And Company · BD MAX™ Vaginal Panel · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This BD MAX Vaginal Panel is a lab test cartridge for vaginal infections such as trichomoniasis, bacterial vaginosis and Candida. Most of its 50 FDA reports describe results that turned out wrong on repeat or outside testing — false positives, false negatives and results that would not reproduce. Four reports involved injuries and no deaths. One recall, closed in July 2019, covered foil bags of extraction tubes that may not have been sealed properly. Reports rose from 3 in the prior 12 months to 28 in the most recent.
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
- 50
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 50 adverse event reports that list this exact device (DI 00382904437121), received between Aug 7, 2020 and Sep 15, 2026 — classified as 4 injuries, 46 malfunctions.
The most frequently reported specific device problem is “False Positive Result” (23 reports).
1 FDA recall record name this device's identifier.
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 16, 2026.
Reports received per month
Recalls naming this device
- Jul 17, 2019Terminated
The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly.
Z-2336-2019 · Root cause: Process control · Recall details · FDA record ↗
Most reported problems
Device problems
- False Positive Result23
- False Negative Result14
- Incorrect, Inadequate or Imprecise Result or Readings11
- Non Reproducible Results3
Patient problems
- No Clinical Signs, Symptoms or Conditions47
- No Consequences Or Impact To Patient3
Recent adverse event reports
The 25 most recent of 50 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 15, 2026False Positive Result
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50777682 ↗MalfunctionSep 15, 2026False Positive Result
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50776439 ↗MalfunctionAug 11, 2026False Positive Result
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50213118 ↗MalfunctionMay 1, 2026Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED THAT DURING USE OF BD MAX¿ VAGINAL PANEL, A DISCREPANT BACTERIAL VAGINOSIS PATIENT RESULT WAS OBTAINED. FIRST RUN WAS BV POSITIVE (OTHER TARGETS WERE UNR). SECOND AND THIRD RUNS WERE ALL NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25059108 ↗MalfunctionApr 22, 2026False Positive Result
IT WAS REPORTED THAT DURING USE OF BD MAX¿ VAGINAL PANEL, A FALSE POSITIVE CANDIDA GLABRATA PATIENT RESULT WAS OBTAINED. THERE WAS NO REPORT OF PATIENT IMPACT. THIS IS REPORT 3 OF 3.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24955111 ↗MalfunctionApr 22, 2026False Positive Result
IT WAS REPORTED THAT DURING USE OF BD MAX¿ VAGINAL PANEL, A FALSE POSITIVE CANDIDA GLABRATA PATIENT RESULT WAS OBTAINED. THERE WAS NO REPORT OF PATIENT IMPACT. THIS IS REPORT 2 OF 3.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24955108 ↗MalfunctionApr 22, 2026False Positive Result
IT WAS REPORTED THAT DURING USE OF BD MAX¿ VAGINAL PANEL, A FALSE POSITIVE CANDIDA GLABRATA PATIENT RESULT WAS OBTAINED. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24952842 ↗MalfunctionApr 7, 2026False Positive Result
IT WAS REPORTED THAT DURING USE OF BD MAX¿ VAGINAL PANEL, A TRICHOMONAS VAGINALIS (TV) FALSE POSITIVE PATIENT RESULT WAS OBTAINED. AN E-SWAB VAGINAL SAMPLE WAS COLLECTED AND SENT TO AN INDEPENDENT LAB WHERE QUANTSTUDIO VAGINAL PANEL WAS TV NEGATIVE. SECOND SPECIMEN WAS COLLECTED AND TESTED AND ALSO GAVE TV NEGATIVE RESULTS. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24808145 ↗MalfunctionApr 7, 2026False Positive Result
IT WAS REPORTED THAT DURING USE OF BD MAX¿ VAGINAL PANEL, A TRICHOMONAS VAGINALIS (TV) FALSE POSITIVE PATIENT RESULT WAS OBTAINED. AN E-SWAB VAGINAL SAMPLE WAS COLLECTED AND SENT TO AN INDEPENDENT LAB WHERE QUANTSTUDIO VAGINAL PANEL WAS TV NEGATIVE. SECOND SPECIMEN WAS COLLECTED AND TESTED AND ALSO GAVE TV NEGATIVE RESULTS. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24808052 ↗MalfunctionApr 7, 2026False Negative Result
IT WAS REPORTED THAT DURING USE OF BD MAX¿ VAGINAL PANEL, A TRICHOMONAS VAGINALIS (TV) FALSE NEGATIVE PATIENT RESULT WAS OBTAINED. SAMPLE WAS RUN ON BD MAX¿ CTGCTV AND WAS TV POSITIVE. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24800616 ↗MalfunctionApr 3, 2026False Negative Result
IT WAS REPORTED THAT DURING USE OF BD MAX¿ VAGINAL PANEL, A FALSE NEGATIVE BACTERIAL VAGINOSIS PATIENT RESULT WAS OBTAINED. CULTURE WAS GARDNERELLA POSITIVE. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24775967 ↗MalfunctionMar 26, 2026False Negative Result
IT WAS REPORTED THAT DURING USE OF BD MAX¿ VAGINAL PANEL, A TRICHOMONAS VAGINALIS (TV) DISCREPANT PATIENT RESULT WAS OBTAINED. INITIAL SWAB TESTED ON BD MAX¿ VAGINAL PANEL AND WAS TV NEGATIVE. INITIAL SWAB REPEATED ON BD MAX¿ VAGINAL PANEL AND WAS TV NEGATIVE AGAIN. SECOND SWAB COLLECTED AND TESTED ON BD MAX¿ VAGINAL PANEL AND WAS TV NEGATIVE. SECOND SWAB REPEATED ON BD MAX¿ VAGINAL PANEL AND GAVE AN INDETERMINATE RESULT. SAMPLE WAS TESTED ON BD MAX¿ CTGCTV2 AND WAS TV POSITIVE. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24698678 ↗MalfunctionMar 26, 2026False Negative Result
IT WAS REPORTED THAT DURING USE OF BD MAX¿ VAGINAL PANEL, A TRICHOMONAS VAGINALIS (TV) DISCREPANT PATIENT RESULT WAS OBTAINED. INITIAL SWAB TESTED ON BD MAX¿ VAGINAL PANEL AND WAS TV NEGATIVE. INITIAL SWAB REPEATED ON BD MAX¿ VAGINAL PANEL AND WAS TV NEGATIVE AGAIN. SECOND SWAB COLLECTED AND TESTED ON BD MAX¿ VAGINAL PANEL AND WAS TV NEGATIVE. SECOND SWAB REPEATED ON BD MAX¿ VAGINAL PANEL AND GAVE AN INDETERMINATE RESULT. SAMPLE WAS TESTED ON BD MAX¿ CTGCTV2 AND WAS TV POSITIVE. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24698677 ↗MalfunctionMar 26, 2026False Negative Result
IT WAS REPORTED THAT DURING USE OF BD MAX¿ VAGINAL PANEL, A TRICHOMONAS VAGINALIS (TV) DISCREPANT PATIENT RESULT WAS OBTAINED. INITIAL SWAB TESTED ON BD MAX¿ VAGINAL PANEL AND WAS TV NEGATIVE. INITIAL SWAB REPEATED ON BD MAX¿ VAGINAL PANEL AND WAS TV NEGATIVE AGAIN. SECOND SWAB COLLECTED AND TESTED ON BD MAX¿ VAGINAL PANEL AND WAS TV NEGATIVE. SECOND SWAB REPEATED ON BD MAX¿ VAGINAL PANEL AND GAVE AN INDETERMINATE RESULT. SAMPLE WAS TESTED ON BD MAX¿ CTGCTV2 AND WAS TV POSITIVE. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24698194 ↗MalfunctionMar 23, 2026False Negative Result
IT WAS REPORTED THAT DURING USE OF BD MAX¿ VAGINAL PANEL, A TRICHOMONAS VAGINALIS (TV) FALSE NEGATIVE PATIENT RESULT WAS OBTAINED. ANOTHER SWAB FROM THE SAME PATIENT WAS TESTED ON BD MAX¿ CTGCTV, AND THE TV RESULT WAS POSITIVE. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24664960 ↗MalfunctionMar 23, 2026False Negative Result
IT WAS REPORTED THAT DURING USE OF BD MAX¿ VAGINAL PANEL, A TRICHOMONAS VAGINALIS (TV) FALSE NEGATIVE PATIENT RESULT WAS OBTAINED. ANOTHER SWAB FROM THE SAME PATIENT WAS TESTED ON BD MAX¿ CTGCTV, AND THE TV RESULT WAS POSITIVE. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24664386 ↗MalfunctionMar 16, 2026False Positive Result
IT WAS REPORTED THAT DURING USE OF BD MAX¿ VAGINAL PANEL, A TRICHOMONAS VAGINALIS (TV) FALSE POSITIVE RESULT WAS OBTAINED. SAMPLE WAS REPEATED ON BD MAX¿ CTGCTV2 AND GAVE A TV NEGATIVE RESULT. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24607720 ↗MalfunctionMar 16, 2026False Positive Result
IT WAS REPORTED THAT DURING USE OF BD MAX¿ VAGINAL PANEL, A TRICHOMONAS VAGINALIS (TV) FALSE POSITIVE RESULT WAS OBTAINED. SAMPLE WAS REPEATED ON BD MAX¿ CTGCTV2 AND GAVE A TV NEGATIVE RESULT. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24607716 ↗MalfunctionFeb 26, 2026Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED THAT DURING USE OF BD MAX¿ VAGINAL PANEL, A DISCREPANT BACTERIAL VAGINOSIS (BV) PATIENT RESULT WAS OBTAINED. INITIAL RUN GAVE TRICHOMONAS VAGINALIS (TV) POSITIVE AND BV NEGATIVE RESULTS. REPEAT ON THE SAME BD MAX¿ INSTRUMENT GAVE TV AND BV POSITIVE RESULTS. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24456398 ↗MalfunctionFeb 3, 2026False Positive Result
IT WAS REPORTED THAT DURING USE OF BD MAX¿ VAGINAL PANEL, A TRICHOMONAS VAGINALIS FALSE POSITIVE PATIENT RESULT WAS OBTAINED. THE FIRST TEST ON THE BD MAX¿ VAGINAL PANEL WAS DUAL POSITIVE FOR BACTERIAL VAGINOSIS (BV) AND TRICHOMONAS VAGINALIS (TV). THE SECOND TEST ON BD MAX¿ VAGINAL PANEL WAS BV POSITIVE, BUT TV NEGATIVE. TEST WAS REPEATED ON BD MAX¿ CTGCTV2 AND WAS ALL NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24251873 ↗MalfunctionFeb 3, 2026False Negative Result
IT WAS REPORTED THAT DURING USE OF THE BD MAX¿ VAGINAL PANEL, A FALSE NEGATIVE TRICHOMONAS VAGINALIS PATIENT RESULT WAS OBTAINED. TEST WAS REPEATED ON BD MAX¿ CTGCTV2 AND WAS TRICHOMONAS VAGINALIS POSITIVE WITH A WEAK PCR CURVE. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24251483 ↗MalfunctionDec 17, 2025False Positive Result; False Positive Result
IT WAS REPORTED THAT DURING USE OF BD MAX¿ VAGINAL PANEL, A PATIENT SAMPLE WAS POSITIVE FOR ALL TARGETS. SAMPLE WAS REPEATED ON BD MAX AND WAS ONLY POSITIVE FOR BACTERIAL VAGINOSIS. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23828500 ↗MalfunctionDec 3, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED THAT DURING USE OF BD MAX¿ VAGINAL PANEL, A BV DISCREPANT PATIENT RESULT WITH AN UNUSUAL PCR CURVE WAS OBTAINED. INITIAL TEST WAS BV NEGATIVE, AND THE REPEAT TEST ON A DIFFERENT BD MAX¿ INSTRUMENT WAS BV POSITIVE. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23707558 ↗MalfunctionDec 3, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED THAT DURING USE OF BD MAX¿ VAGINAL PANEL, A BV DISCREPANT PATIENT RESULT WITH AN UNUSUAL PCR CURVE WAS OBTAINED. INITIAL TEST WAS BV NEGATIVE, AND THE REPEAT TEST ON A DIFFERENT BD MAX¿ INSTRUMENT WAS BV POSITIVE. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23707543 ↗MalfunctionDec 3, 2025False Negative Result; False Negative Result
IT WAS REPORTED THAT DURING USE OF BD MAX¿ VAGINAL PANEL, A FALSE NEGATIVE TRICHOMONAS VAGINALIS (TV) PATIENT RESULT WAS OBTAINED. SAMPLE TESTED TV POSITIVE ON BD MAX¿ CTGCTV2 ON 2 DIFFERENT BD MAX INSTRUMENTS, AND TV NEGATIVE ON 2 DIFFERENT BD MAX INSTRUMENTS ON BD MAX¿ VAGINAL PANEL. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23707103 ↗
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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 · each recall links to the FDA recall notice
- 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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