BD MAX™ Extended Enteric Bacterial Panel 443812Recalls & reported problems
Becton, Dickinson And Company · Kit BD MAX EXT Enteric Bacterial Panel · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This BD MAX Extended Enteric Bacterial Panel is a lab test kit for bacteria that cause stomach and intestinal infections. It has 107 reports, with no deaths and no injuries. Most reports describe false positive results, and the examples given involve Vibrio bacteria. There was 1 recall, now closed, started in July 2019 because foil bags holding extraction tubes may not have been sealed properly.
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
- 114
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 114 adverse event reports that list this exact device (DI 00382904438128), received between Jan 27, 2021 and Sep 3, 2026 — classified as 114 malfunctions.
The most frequently reported specific device problem is “False Positive Result” (89 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-2338-2019 · Root cause: Process control · Recall details · FDA record ↗
Most reported problems
Device problems
- False Positive Result89
- Incorrect, Inadequate or Imprecise Result or Readings23
- False Negative Result2
Patient problems
- No Clinical Signs, Symptoms or Conditions113
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 25 most recent of 114 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 3, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50589677 ↗MalfunctionSep 3, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50589675 ↗MalfunctionSep 3, 2026False Positive Result
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50587839 ↗MalfunctionSep 3, 2026False Positive Result
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50587833 ↗MalfunctionSep 3, 2026False Positive Result
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50587810 ↗MalfunctionSep 3, 2026False Positive Result
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50587802 ↗MalfunctionSep 3, 2026False Positive Result
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50587762 ↗MalfunctionAug 11, 2026False Positive Result
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50208841 ↗MalfunctionJul 28, 2026False Positive Result
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50061172 ↗MalfunctionJul 27, 2026False Positive Result
It was reported that during use of BD MAX¿ EXT Enteric Bacterial Panel, a False Positive Vibrio patient result with an unusual PCR curve was obtained.There was no report of patient impact.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50022160 ↗MalfunctionMay 26, 2026Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED THAT DURING USE OF BD MAX¿ EXT ENTERIC BACTERIAL PANEL; A VIBRIO DISCREPANT PATIENT RESULT WAS OBTAINED. INITIAL TEST WAS VIBRIO POSITIVE. REPEAT TEST WAS VIBRIO NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25277077 ↗MalfunctionMay 26, 2026Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED THAT DURING USE OF BD MAX¿ EXT ENTERIC BACTERIAL PANEL, A VIBRIO DISCREPANT PATIENT RESULT WAS OBTAINED. INITIAL TEST WAS VIBRIO POSITIVE. REPEAT TEST WAS VIBRIO NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25277076 ↗MalfunctionMar 9, 2026False Positive Result
IT WAS REPORTED THAT DURING USE OF BD MAX¿ EXT ENTERIC BACTERIAL PANEL, A VIBRIO FALSE POSITIVE PATIENT RESULT WAS OBTAINED. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24547117 ↗MalfunctionMar 9, 2026False Positive Result
IT WAS REPORTED THAT DURING USE OF BD MAX¿ EXT ENTERIC BACTERIAL PANEL, A VIBRIO FALSE POSITIVE PATIENT RESULT WAS OBTAINED. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24547079 ↗MalfunctionMar 9, 2026False Positive Result
IT WAS REPORTED THAT DURING USE OF BD MAX¿ EXT ENTERIC BACTERIAL PANEL, A VIBRIO FALSE POSITIVE PATIENT RESULT WAS OBTAINED. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24547077 ↗MalfunctionMar 5, 2026False Positive Result
IT WAS REPORTED THAT DURING USE OF BD MAX¿ EXT ENTERIC BACTERIAL PANEL, A VIBRIO FALSE POSITIVE PATIENT RESULT WAS OBTAINED. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24522856 ↗MalfunctionFeb 24, 2026False Positive Result
IT WAS REPORTED THAT DURING USE OF BD MAX¿ EXT ENTERIC BACTERIAL PANEL, A VIBRIO FALSE POSITIVE PATIENT RESULT WAS OBTAINED. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24433786 ↗MalfunctionFeb 12, 2026False Positive Result
IT WAS REPORTED THAT DURING USE OF BD MAX¿ EXT ENTERIC BACTERIAL PANEL, A FALSE POSITIVE VIBRIO PATIENT RESULT WITH A WEEK PCR CURVE WAS OBTAINED. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24322950 ↗MalfunctionFeb 12, 2026False Positive Result
IT WAS REPORTED THAT DURING USE OF BD MAX¿ EXT ENTERIC BACTERIAL PANEL, A FALSE POSITIVE VIBRIO PATIENT RESULT WITH A WEEK PCR CURVE WAS OBTAINED. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24322784 ↗MalfunctionFeb 12, 2026False Positive Result
IT WAS REPORTED THAT DURING USE OF BD MAX¿ EXT ENTERIC BACTERIAL PANEL, A FALSE POSITIVE VIBRIO PATIENT RESULT WITH A WEEK PCR CURVE WAS OBTAINED. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24322776 ↗MalfunctionFeb 12, 2026False Positive Result
IT WAS REPORTED THAT DURING USE OF BD MAX¿ EXT ENTERIC BACTERIAL PANEL, A FALSE POSITIVE VIBRIO PATIENT RESULT WITH A WEEK PCR CURVE WAS OBTAINED. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24322775 ↗MalfunctionDec 17, 2025False Positive Result; False Positive Result
IT WAS REPORTED THAT DURING USE OF BD MAX¿ EXT ENTERIC BACTERIAL PANEL, A FALSE POSITIVE VIBRIO PATIENT RESULT WITH A WEEK PCR CURVE WAS OBTAINED. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23828128 ↗MalfunctionDec 16, 2025False Positive Result; False Positive Result
REPORT 1 OF 5: IT WAS REPORTED THAT DURING USE OF BD MAX¿ EXT ENTERIC BACTERIAL PANEL, A FALSE POSITIVE VIBRIO PATIENT RESULT WITH AN UNUSUAL PCR CURVE WAS OBTAINED. TEST WAS VIBRIO NEGATIVE UPON REPEAT. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23816478 ↗MalfunctionDec 16, 2025False Positive Result; False Positive Result
REPORT 2 OF 5: IT WAS REPORTED THAT DURING USE OF BD MAX¿ EXT ENTERIC BACTERIAL PANEL, A FALSE POSITIVE VIBRIO PATIENT RESULT WITH AN UNUSUAL PCR CURVE WAS OBTAINED. TEST WAS VIBRIO NEGATIVE UPON REPEAT. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23816303 ↗MalfunctionDec 16, 2025False Positive Result; False Positive Result
REPORT 5 OF 5: IT WAS REPORTED THAT DURING USE OF BD MAX¿ EXT ENTERIC BACTERIAL PANEL, A FALSE POSITIVE VIBRIO PATIENT RESULT WITH AN UNUSUAL PCR CURVE WAS OBTAINED. TEST WAS VIBRIO NEGATIVE UPON REPEAT. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23816299 ↗
Other Gastrointestinal pathogen panel multiplex nucleic acid-based assay system devices
- FilmArray® Gastrointestinal (GI) Panel RFIT-ASY-0116Biofire Diagnostics, LLC · Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System6 recalls2 deaths24 reports
- BD MAX™ Enteric Bacterial Panel 442963Becton, Dickinson And Company · Gastrointestinal pathogen panel multiplex nucleic acid-based assay system2 recalls102 reports
- BD MAX™ Enteric Parasite Panel 442960Becton, Dickinson And Company · Gastrointestinal pathogen panel multiplex nucleic acid-based assay system1 recall70 reports
- Enteric Pathogens (EP) Stool Sample Preparation Kit 30-002-023Luminex Corporation · Gastrointestinal pathogen panel multiplex nucleic acid-based assay system2 recalls1 report
- xTAG® Gastrointestinal Pathogen Panel (GPP) I032C0316Luminex Molecular Diagnostics, Inc · Gastrointestinal pathogen panel multiplex nucleic acid-based assay system1 recall0 reports
- FilmArray® Gastrointestinal (GI) Panel RFIT-ASY-0104Biofire Diagnostics, LLC · Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System1 recall0 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 · 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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