BD Respiratory Viral Panel for BD MAX™ System 445373Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00382904453732), received between Aug 19, 2024 and Mar 16, 2026 — classified as 8 malfunctions.

The most frequently reported specific device problem is “False Positive Result” (5 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, 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 18, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 16, 2026False Negative Result

  IT WAS REPORTED THAT DURING USE OF BD MAX¿ RESPIRATORY VIRAL PANEL, A FALSE NEGATIVE INFLUENZA A PATIENT RESULT WAS OBTAINED. SAMPLE WAS REPEAT TESTED AND REMAINED INFLUENZA A NEGATIVE. SAMPLE WAS THEN TESTED ON FILMARRAY, WHICH IDENTIFIED THE SAMPLE AS INFLUENZA A POSITIVE. INFLUENZA A TYPING LDT WAS ALSO PERFORMED ON RESIDUAL SAMPLE AND THE RESULT WAS INFLUENZA A POSITIVE. THERE WAS NO REPORT OF PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24605267 ↗
• MalfunctionMar 16, 2026False Negative Result

  IT WAS REPORTED THAT DURING USE OF BD MAX¿ RESPIRATORY VIRAL PANEL, A FALSE NEGATIVE INFLUENZA A PATIENT RESULT WAS OBTAINED. SAMPLE WAS REPEAT TESTED AND REMAINED INFLUENZA A NEGATIVE. SAMPLE WAS THEN TESTED ON FILMARRAY, WHICH IDENTIFIED THE SAMPLE AS INFLUENZA A POSITIVE. INFLUENZA A TYPING LDT WAS ALSO PERFORMED ON RESIDUAL SAMPLE AND THE RESULT WAS INFLUENZA A POSITIVE. THERE WAS NO REPORT OF PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24604950 ↗
• MalfunctionOct 25, 2024False Positive Result; False Positive Result

  REPORT 4 OF 5: IT WAS REPORTED THAT DURING USE OF THE BD RESPIRATORY VIRAL PANEL FOR BD MAX¿ SYSTEM, A FLU A FALSE POSITIVE PATIENT RESULT WAS OBTAINED. SAMPLES WERE REPEATED ON CEPHEID GENEXPERT AND WERE NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20533212 ↗
• MalfunctionOct 25, 2024False Positive Result; False Positive Result

  REPORT 5 OF 5: IT WAS REPORTED THAT DURING USE OF THE BD RESPIRATORY VIRAL PANEL FOR BD MAX¿ SYSTEM, A FLU A FALSE POSITIVE PATIENT RESULT WAS OBTAINED. SAMPLES WERE REPEATED ON CEPHEID GENEXPERT AND WERE NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20533137 ↗
• MalfunctionOct 25, 2024False Positive Result; False Positive Result

  REPORT 2 OF 5: IT WAS REPORTED THAT DURING USE OF THE BD RESPIRATORY VIRAL PANEL FOR BD MAX¿ SYSTEM, A FLU A FALSE POSITIVE PATIENT RESULT WAS OBTAINED. SAMPLES WERE REPEATED ON CEPHEID GENEXPERT AND WERE NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20532343 ↗
• MalfunctionOct 25, 2024False Positive Result; False Positive Result

  REPORT 3 OF 5: IT WAS REPORTED THAT DURING USE OF THE BD RESPIRATORY VIRAL PANEL FOR BD MAX¿ SYSTEM, A FLU A FALSE POSITIVE PATIENT RESULT WAS OBTAINED. SAMPLES WERE REPEATED ON CEPHEID GENEXPERT AND WERE NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20532236 ↗
• MalfunctionOct 25, 2024False Positive Result; False Positive Result

  REPORT 1 OF 5: IT WAS REPORTED THAT DURING USE OF THE BD RESPIRATORY VIRAL PANEL FOR BD MAX¿ SYSTEM, A FLU A FALSE POSITIVE PATIENT RESULT WAS OBTAINED. SAMPLES WERE REPEATED ON CEPHEID GENEXPERT AND WERE NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20531999 ↗
• MalfunctionAug 19, 2024Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT DURING USE OF BD RESPIRATORY VIRAL PANEL FOR BD MAX¿ SYSTEM, A DISCREPANT PATIENT COVID RESULT WAS OBTAINED. THE SAMPLE WAS POSITIVE, BUT THEN UPON REPEAT IT WAS NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19999612 ↗