BD MAX™ Enteric Bacterial Panel 442963Recalls & reported problems

Summary

The FDA's MAUDE database contains 102 adverse event reports that list this exact device (DI 00382904429638), received between Sep 18, 2020 and Sep 29, 2026 — classified as 3 injuries, 99 malfunctions.

The most frequently reported specific device problem is “False Positive Result” (69 reports).

2 FDA recall records 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.

Recalls naming this device

1. Jul 17, 2019Terminated

   The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly.

   Z-2330-2019 · Root cause: Process control · FDA record ↗

2. Jan 14, 2019Terminated

   False negative results with the BD MAX Extended Enteric Bacterial Panel when testing specifically for Enterotoxigenic Escherichia coli (ETEC) and Plesiomonas shigelloides targets of the BD MAX Extended Enteric Bacterial Panel assay.

   Z-0981-2019 · Root cause: Nonconforming Material/Component · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 102 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026False Positive Result

  It was reported that during use of BD MAX¿ Enteric Bacterial Panel, a False Positive Campylobacter patient result was obtained.There was no report of patient impact.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50931720 ↗
• MalfunctionSep 18, 2026False Positive Result

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50820934 ↗
• MalfunctionSep 15, 2026False Negative Result

  Report 2 of 2:It was reported that during use of BD MAX¿ Bacterial Panel, a False Negative patient result was obtained.Specimen was retested using same assay and again produced a Negative Salmonella result.The specimen was also tested by culture and Salmonella was recovered.Repeat culture of specimen again yielded Salmonella.There was no report of patient impact.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50773744 ↗
• MalfunctionSep 15, 2026False Negative Result

  Report 1 of 2:It was reported that during use of BD MAX¿ Bacterial Panel, a False Negative patient result was obtained.Specimen was retested using same assay and again produced a Negative Salmonella result.The specimen was also tested by culture and Salmonella was recovered.Repeat culture of specimen again yielded Salmonella.There was no report of patient impact.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50773382 ↗
• MalfunctionAug 11, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50207422 ↗
• MalfunctionMay 6, 2026False Negative Result

  IT WAS REPORTED THAT DURING USE OF BD MAX¿ BACTERIAL PANEL, A FALSE NEGATIVE SALMONELLA PATIENT RESULT WAS OBTAINED. THE BD MAX REPORTED A NEGATIVE RESULT FOR SALMONELLA SPP. TWICE, ALTHOUGH SALMONELLA GREW IN CULTURE. AGGLUTINATION IDENTIFIED SEROGROUP D, AND FURTHER DIAGNOSTIC TESTING CONFIRMED THE ISOLATE AS SALMONELLA ENTERITIDIS. THERE WAS NO REPORT OF PATIENT IMPACT. THIS IS REPORT 2 OF 2.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25104820 ↗
• MalfunctionMay 6, 2026False Negative Result

  IT WAS REPORTED THAT DURING USE OF BD MAX¿ BACTERIAL PANEL, A FALSE NEGATIVE SALMONELLA PATIENT RESULT WAS OBTAINED. THE BD MAX REPORTED A NEGATIVE RESULT FOR SALMONELLA SPP. TWICE, ALTHOUGH SALMONELLA GREW IN CULTURE. AGGLUTINATION IDENTIFIED SEROGROUP D, AND FURTHER DIAGNOSTIC TESTING CONFIRMED THE ISOLATE AS SALMONELLA ENTERITIDIS. THERE WAS NO REPORT OF PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25096683 ↗
• MalfunctionFeb 23, 2026False Positive Result

  IT WAS REPORTED THAT DURING USE OF BD MAX¿ ENTERIC BACTERIAL PANEL, A FALSE POSITIVE CAMPYLOBACTER PATIENT RESULT WITH AN UNUSUAL PCR CURVE WAS OBTAINED. TEST WAS REPEATED AND WAS CAMPYLOBACTER NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24416042 ↗
• MalfunctionFeb 23, 2026False Positive Result

  IT WAS REPORTED THAT DURING USE OF BD MAX¿ ENTERIC BACTERIAL PANEL, A FALSE POSITIVE CAMPYLOBACTER PATIENT RESULT WITH AN UNUSUAL PCR CURVE WAS OBTAINED. TEST WAS REPEATED AND WAS CAMPYLOBACTER NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24416027 ↗
• MalfunctionFeb 23, 2026False Positive Result

  IT WAS REPORTED THAT DURING USE OF BD MAX¿ ENTERIC BACTERIAL PANEL, A FALSE POSITIVE CAMPYLOBACTER PATIENT RESULT WITH AN UNUSUAL PCR CURVE WAS OBTAINED. TEST WAS REPEATED AND WAS CAMPYLOBACTER NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24416024 ↗
• MalfunctionDec 3, 2025False Negative Result; False Negative Result

  IT WAS REPORTED THAT DURING USE OF BD MAX¿ ENTERIC BACTERIAL PANEL, A FALSE NEGATIVE SALMONELLA PATIENT RESULT WAS OBTAINED. A HEKTOEN PLATE WAS SEEDED IN PARALLEL WITH THE BD MAX TEST. THERE WAS NO REPORT OF PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23707797 ↗
• MalfunctionDec 3, 2025False Negative Result; False Negative Result

  IT WAS REPORTED THAT DURING USE OF BD MAX¿ ENTERIC BACTERIAL PANEL, A FALSE NEGATIVE SALMONELLA PATIENT RESULT WAS OBTAINED. A HEKTOEN PLATE WAS SEEDED IN PARALLEL WITH THE BD MAX TEST. THERE WAS NO REPORT OF PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23707777 ↗
• MalfunctionDec 3, 2025False Negative Result; False Negative Result

  IT WAS REPORTED THAT DURING USE OF BD MAX¿ ENTERIC BACTERIAL PANEL, A FALSE NEGATIVE SALMONELLA PATIENT RESULT WAS OBTAINED. A HEKTOEN PLATE WAS SEEDED IN PARALLEL WITH THE BD MAX TEST. THERE WAS NO REPORT OF PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23707772 ↗
• MalfunctionDec 3, 2025False Negative Result; False Negative Result

  IT WAS REPORTED THAT DURING USE OF BD MAX¿ ENTERIC BACTERIAL PANEL, A FALSE NEGATIVE SALMONELLA PATIENT RESULT WAS OBTAINED. A HEKTOEN PLATE WAS SEEDED IN PARALLEL WITH THE BD MAX TEST. THERE WAS NO REPORT OF PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23707555 ↗
• MalfunctionDec 3, 2025False Negative Result; False Negative Result

  IT WAS REPORTED THAT DURING USE OF BD MAX¿ ENTERIC BACTERIAL PANEL, A FALSE NEGATIVE SALMONELLA PATIENT RESULT WAS OBTAINED. THE FIRST MAX TEST WAS SALMONELLA NEGATIVE, AND THE REPEAT MAX TEST WAS SALMONELLA POSITIVE. THERE WAS NO REPORT OF PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23706462 ↗
• MalfunctionAug 28, 2025False Positive Result; False Positive Result

  IT WAS REPORTED WHILE USING BD MAX¿ ENTERIC BACTERIAL PANEL, THERE WAS A FALSE POSITIVE RESULT. THERE WAS NO REPORT OF PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22912622 ↗
• MalfunctionJul 31, 2025False Positive Result; False Positive Result

  REPORT 1 OF 3: IT WAS REPORTED THAT DURING USE OF BD MAX¿ ENTERIC BACTERIAL PANEL, A CAMPYLOBACTER FALSE POSITIVE PATIENT RESULT WAS OBTAINED. TEST WAS REPEATED TWICE ON BD MAX¿ AND WAS NEGATIVE, AND COULD NOT BE SUBCULTURED. THERE WAS NO REPORT OF PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22677997 ↗
• MalfunctionJul 31, 2025False Positive Result; False Positive Result

  REPORT 3 OF 3: IT WAS REPORTED THAT DURING USE OF BD MAX¿ ENTERIC BACTERIAL PANEL, A CAMPYLOBACTER FALSE POSITIVE PATIENT RESULT WAS OBTAINED. TEST WAS REPEATED TWICE ON BD MAX¿ AND WAS NEGATIVE AND COULD NOT BE SUBCULTURED. THERE WAS NO REPORT OF PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22677993 ↗
• MalfunctionJul 31, 2025False Positive Result; False Positive Result

  REPORT 2 OF 3: IT WAS REPORTED THAT DURING USE OF BD MAX¿ ENTERIC BACTERIAL PANEL, A CAMPYLOBACTER FALSE POSITIVE PATIENT RESULT WAS OBTAINED. TEST WAS REPEATED TWICE ON BD MAX¿ AND WAS NEGATIVE AND COULD NOT BE SUBCULTURED. THERE WAS NO REPORT OF PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22677992 ↗
• MalfunctionJun 18, 2025False Positive Result; False Positive Result

  REPORT 2 OF 6: IT WAS REPORTED THAT DURING USE OF BD MAX¿ ENTERIC BACTERIAL PANEL, A FALSE POSITIVE SALMONELLA PATIENT RESULT WAS OBTAINED. MAX TEST WAS REPEATED AND WAS SALMONELLA NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22287249 ↗
• MalfunctionJun 18, 2025False Positive Result; False Positive Result

  REPORT 5 OF 6: IT WAS REPORTED THAT DURING USE OF BD MAX¿ ENTERIC BACTERIAL PANEL, A FALSE POSITIVE SALMONELLA PATIENT RESULT WAS OBTAINED. MAX TEST WAS REPEATED AND WAS SALMONELLA NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22287248 ↗
• MalfunctionJun 18, 2025False Positive Result; False Positive Result

  REPORT 6 OF 6: IT WAS REPORTED THAT DURING USE OF BD MAX¿ ENTERIC BACTERIAL PANEL, A FALSE POSITIVE SALMONELLA PATIENT RESULT WAS OBTAINED. MAX TEST WAS REPEATED AND WAS SALMONELLA NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22287246 ↗
• MalfunctionJun 18, 2025False Positive Result; False Positive Result

  REPORT 4 OF 6: IT WAS REPORTED THAT DURING USE OF BD MAX¿ ENTERIC BACTERIAL PANEL, A FALSE POSITIVE SALMONELLA PATIENT RESULT WAS OBTAINED. MAX TEST WAS REPEATED AND WAS SALMONELLA NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22287243 ↗
• MalfunctionJun 18, 2025False Positive Result; False Positive Result

  REPORT 1 OF 6: IT WAS REPORTED THAT DURING USE OF BD MAX¿ ENTERIC BACTERIAL PANEL, A FALSE POSITIVE SALMONELLA PATIENT RESULT WAS OBTAINED. MAX TEST WAS REPEATED AND WAS SALMONELLA NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22287242 ↗
• MalfunctionJun 18, 2025False Positive Result; False Positive Result

  REPORT 3 OF 6: IT WAS REPORTED THAT DURING USE OF BD MAX¿ ENTERIC BACTERIAL PANEL, A FALSE POSITIVE SALMONELLA PATIENT RESULT WAS OBTAINED. MAX TEST WAS REPEATED AND WAS SALMONELLA NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22287241 ↗