BD MAX™ Enteric Viral Panel 443985Recalls & reported problems
Becton, Dickinson And Company · Kit BD MAX Enteric Viral Panel · Class 2
Quick summary
This BD MAX Enteric Viral Panel is a laboratory test kit for intestinal viruses. Most of the 135 reports describe wrong positive results, mainly for norovirus and rotavirus. There are no deaths or injuries. The 1 recall, started in July 2019 and now closed, concerns foil bags containing extraction tubes that 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
- 135
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 135 adverse event reports that list this exact device (DI 00382904439859), received between Feb 2, 2021 and May 5, 2026 — classified as 135 malfunctions.
The most frequently reported specific device problem is “False Positive Result” (118 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. How this data works · Data updated Oct 13, 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-2339-2019 · Root cause: Process control · FDA record ↗
Most reported problems
Device problems
- False Positive Result118
- Incorrect, Inadequate or Imprecise Result or Readings11
- False Negative Result7
- Non Reproducible Results1
Patient problems
- No Clinical Signs, Symptoms or Conditions135
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 25 most recent of 135 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 5, 2026False Positive Result
IT WAS REPORTED THAT DURING USE OF BD MAX¿ ENTERIC VIRAL PANEL, AN UNSPECIFIED NUMBER OF LOW FALSE POSITIVE NOROVIRUS AND ROTOVIRUS PATIENT RESULTS WERE OBTAINED.LOW POSITIVE SAMPLES WERE RETESTED AND WERE NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25085968 ↗MalfunctionMay 5, 2026False Positive Result
IT WAS REPORTED THAT DURING USE OF BD MAX¿ ENTERIC VIRAL PANEL, AN UNSPECIFIED NUMBER OF LOW FALSE POSITIVE NOROVIRUS AND ROTOVIRUS PATIENT RESULTS WERE OBTAINED. LOW POSITIVE SAMPLES WERE RETESTED AND WERE NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25085967 ↗MalfunctionMay 5, 2026False Positive Result
IT WAS REPORTED THAT DURING USE OF BD MAX¿ ENTERIC VIRAL PANEL, AN UNSPECIFIED NUMBER OF LOW FALSE POSITIVE NOROVIRUS AND ROTOVIRUS PATIENT RESULTS WERE OBTAINED. LOW POSITIVE SAMPLES WERE RETESTED AND WERE NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25085965 ↗MalfunctionMay 5, 2026False Positive Result
IT WAS REPORTED THAT DURING USE OF BD MAX¿ ENTERIC VIRAL PANEL, AN UNSPECIFIED NUMBER OF LOW FALSE POSITIVE NOROVIRUS AND ROTOVIRUS PATIENT RESULTS WERE OBTAINED. LOW POSITIVE SAMPLES WERE RETESTED AND WERE NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25085963 ↗MalfunctionMay 5, 2026False Positive Result
IT WAS REPORTED THAT DURING USE OF BD MAX¿ ENTERIC VIRAL PANEL, AN UNSPECIFIED NUMBER OF LOW FALSE POSITIVE NOROVIRUS AND ROTOVIRUS PATIENT RESULTS WERE OBTAINED. LOW POSITIVE SAMPLES WERE RETESTED AND WERE NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25085948 ↗MalfunctionApr 28, 2026False Positive Result
IT WAS REPORTED THAT DURING USE OF BD MAX¿ ENTERIC VIRAL PANEL, A FALSE POSITIVE ASTROVIRUS PATIENT RESULT WAS OBTAINED. INITIAL TEST WAS BOTH SAPOVIRUS AND ASTROVIRUS POSITIVE. REPEAT OF THE SAMPLE GAVE SAPOVIRUS POSITIVE ONLY RESULT. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25022183 ↗MalfunctionApr 3, 2026False Positive Result
IT WAS REPORTED THAT DURING USE OF THE BD MAX¿ ENTERIC VIRAL PANEL , A DISCREPANT ASTROVIRUS PATIENT RESULT WAS OBTAINED. INITIAL TEST WAS ASTROVIRUS POSITIVE. TEST WAS REPEATED AND WAS ASTROVIRUS NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24778065 ↗MalfunctionApr 2, 2026False Positive Result
IT WAS REPORTED THAT DURING USE OF THE BD MAX¿ ENTERIC VIRAL PANEL , A DISCREPANT ASTROVIRUS PATIENT RESULT WAS OBTAINED. INITIAL TEST WAS ASTROVIRUS POSITIVE. TEST WAS REPEATED AND WAS ASTROVIRUS NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24765504 ↗MalfunctionApr 2, 2026False Positive Result
IT WAS REPORTED THAT DURING USE OF THE BD MAX¿ ENTERIC VIRAL PANEL , A DISCREPANT ASTROVIRUS PATIENT RESULT WAS OBTAINED. INITIAL TEST WAS ASTROVIRUS POSITIVE. TEST WAS REPEATED AND WAS ASTROVIRUS NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24765503 ↗MalfunctionFeb 17, 2026False Positive Result
IT WAS REPORTED THAT DURING USE OF BD MAX¿ ENTERIC VIRAL PANEL, A FALSE POSITIVE NOROVIRUS PATIENT RESULT WAS OBTAINED. TEST WAS REPEATED ON MAX AND WAS NOROVIRUS NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24367787 ↗MalfunctionFeb 10, 2026False Positive Result
IT WAS REPORTED THAT DURING USE OF BD MAX¿ ENTERIC VIRAL PANEL, AN UNSPECIFIED NUMBER OF FALSE POSITIVE ADENOVIRUS PATIENT RESULTS WERE OBTAINED. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24307416 ↗MalfunctionFeb 6, 2026False Positive Result
IT WAS REPORTED THAT DURING USE OF BD MAX¿ ENTERIC VIRAL PANEL, A FALSE POSITIVE NOROVIRUS PATIENT RESULT WAS OBTAINED. TEST WAS REPEATED ON MAX AND WAS NOROVIRUS NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24282869 ↗MalfunctionFeb 4, 2026False Positive Result
REPORT 6 OF 6: IT WAS REPORTED THAT DURING USE OF BD MAX¿ ENTERIC VIRAL PANEL, A FALSE POSITIVE PATIENT RESULT WAS OBTAINED. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24261926 ↗MalfunctionFeb 4, 2026False Positive Result
REPORT 2 OF 6: IT WAS REPORTED THAT DURING USE OF BD MAX¿ ENTERIC VIRAL PANEL, A FALSE POSITIVE PATIENT RESULT WAS OBTAINED. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24261923 ↗MalfunctionFeb 4, 2026False Positive Result
REPORT 4 OF 6: IT WAS REPORTED THAT DURING USE OF BD MAX¿ ENTERIC VIRAL PANEL, A FALSE POSITIVE PATIENT RESULT WAS OBTAINED. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24261922 ↗MalfunctionFeb 4, 2026False Positive Result
REPORT 3 OF 6: IT WAS REPORTED THAT DURING USE OF BD MAX¿ ENTERIC VIRAL PANEL, A FALSE POSITIVE PATIENT RESULT WAS OBTAINED. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24261920 ↗MalfunctionFeb 4, 2026False Positive Result
REPORT 5 OF 6: IT WAS REPORTED THAT DURING USE OF BD MAX¿ ENTERIC VIRAL PANEL, A FALSE POSITIVE PATIENT RESULT WAS OBTAINED. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24261905 ↗MalfunctionJan 21, 2026False Positive Result
IT WAS REPORTED THAT DURING USE OF THE BD MAX¿ ENTERIC VIRAL PANEL, A FALSE POSITIVE NOROVIRUS PATIENT RESULT WAS OBTAINED. TESTING OF THIS SPECIMEN WAS REPEATED AND WAS NEGATIVE FOR NOROVIRUS. SPECIMEN WAS ALSO SENT OUT FOR CONFIRMATORY TESTING AND WAS NEGATIVE FOR NOROVIRUS. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24133379 ↗MalfunctionJan 15, 2026False Positive Result
IT WAS REPORTED THAT DURING USE OF BD MAX¿ ENTERIC VIRAL PANEL, A FALSE POSITIVE PATIENT RESULT WAS OBTAINED. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24081527 ↗MalfunctionJan 9, 2026False Positive Result
REPORT 2 OF 2. IT WAS REPORTED THAT DURING USE OF BD MAX¿ ENTERIC VIRAL PANEL, A FALSE POSITIVE NOROVIRUS PATIENT RESULT WITH AN UNUSUAL PCR CURVE WAS OBTAINED. SAMPLE WAS TESTED ON BIOFIRE AND CEPHEID AND WAS NEGATIVE FOR NOROVIRUS. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24029035 ↗MalfunctionJan 9, 2026False Positive Result
REPORT 2 OF 2: IT WAS REPORTED THAT DURING USE OF BD MAX¿ ENTERIC VIRAL PANEL, A FALSE POSITIVE NOROVIRUS PATIENT RESULT WITH AN UNUSUAL PCR CURVE WAS OBTAINED. SAMPLE WAS TESTED ON BIOFIRE AND CEPHEID AND WAS NEGATIVE FOR NOROVIRUS. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24029029 ↗MalfunctionDec 18, 2025False Negative Result; False Negative Result
IT WAS REPORTED THAT DURING USE OF BD MAX¿ ENTERIC VIRAL PANEL, A FALSE NEGATIVE NOROVIRUS PATIENT RESULT WAS OBTAINED. SAMPLE WAS REPEATED ON GENEXPERT AND BIOFIRE AND WAS NOROVIRUS POSITIVE. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23842885 ↗MalfunctionDec 18, 2025False Positive Result; Incorrect, Inadequate or Imprecise Result or Readings; False Positive Result; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED THAT DURING USE OF BD MAX¿ ENTERIC VIRAL PANEL, A DISCREPANT SAPOVIRUS PATIENT RESULT WAS OBTAINED. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23842488 ↗MalfunctionDec 18, 2025False Negative Result; False Negative Result
IT WAS REPORTED THAT DURING USE OF BD MAX¿ ENTERIC VIRAL PANEL, A FALSE NEGATIVE NOROVIRUS PATIENT RESULT WAS OBTAINED. SAMPLE WAS REPEATED ON GENEXPERT AND BIOFIRE AND WAS NOROVIRUS POSITIVE. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23842473 ↗MalfunctionDec 17, 2025False Positive Result; False Positive Result
REPORT 2 OF 2: IT WAS REPORTED THAT DURING USE OF BD MAX¿ ENTERIC VIRAL PANEL, A FALSE POSITIVE NOROVIRUS 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 23828881 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.