BD MAX™ StaphSR 443419Recalls & reported problems
Becton, Dickinson And Company · BD MAX™ StaphSR · Class 2
Quick summary
This BD MAX StaphSR is a laboratory system that quickly detects *Staph aureus* and methicillin resistance in patient samples. Most of its 44 reports describe test results that came back wrong — samples read as negative when the bug was actually present, or positive when it was not. There are 43 malfunctions, 1 death and no reported injuries. Two recalls, both started in July 2019 and now closed, involved foil bags of extraction tubes that may not have been sealed properly, allowing reagent contamination.
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
- 44
- Deaths reported
- 1
- Injuries reported
- 0
- Recalls naming it
- 2
Summary
The FDA's MAUDE database contains 44 adverse event reports that list this exact device (DI 00382904434199), received between Dec 28, 2017 and Nov 5, 2025 — classified as 1 death, 43 malfunctions.
The most frequently reported specific device problem is “False Negative Result” (30 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.
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-2333-2019 · Root cause: Process control · FDA record ↗
- Jul 17, 2019Terminated
The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly.
Z-2332-2019 · Root cause: Process control · FDA record ↗
Most reported problems
Device problems
- False Negative Result30
- False Positive Result13
- Incorrect, Inadequate or Imprecise Result or Readings10
- Incorrect Or Inadequate Test Results1
Patient problems
- No Clinical Signs, Symptoms or Conditions43
- Death1
Recent adverse event reports
The 25 most recent of 44 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 5, 2025False Negative Result; False Negative Result
REPORT 10 OF 10: IT WAS REPORTED THAT DURING USE OF BD MAX¿ STAPHSR, A MREJ FALSE NEGATIVE RESULT WAS OBTAINED. MREJ WAS DETECTED IN GENEXPERT. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23476210 ↗MalfunctionNov 5, 2025False Negative Result; False Negative Result
REPORT 8 OF 10: IT WAS REPORTED THAT DURING USE OF BD MAX¿ STAPHSR, A MREJ FALSE NEGATIVE RESULT WAS OBTAINED. MREJ WAS DETECTED IN GENEXPERT. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23476207 ↗MalfunctionNov 5, 2025False Negative Result; False Negative Result
REPORT 4 OF 10: IT WAS REPORTED THAT DURING USE OF BD MAX¿ STAPHSR, A MREJ FALSE NEGATIVE RESULT WAS OBTAINED. MREJ WAS DETECTED IN GENEXPERT. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23476206 ↗MalfunctionNov 5, 2025False Negative Result; False Negative Result
REPORT 7 OF 10: IT WAS REPORTED THAT DURING USE OF BD MAX¿ STAPHSR, A MREJ FALSE NEGATIVE RESULT WAS OBTAINED. MREJ WAS DETECTED IN GENEXPERT. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23476205 ↗MalfunctionNov 5, 2025False Negative Result; False Negative Result
REPORT 9 OF 10: IT WAS REPORTED THAT DURING USE OF BD MAX¿ STAPHSR, A MREJ FALSE NEGATIVE RESULT WAS OBTAINED. MREJ WAS DETECTED IN GENEXPERT. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23476203 ↗MalfunctionNov 5, 2025False Negative Result; False Negative Result
REPORT 6 OF 10: IT WAS REPORTED THAT DURING USE OF BD MAX¿ STAPHSR, A MREJ FALSE NEGATIVE RESULT WAS OBTAINED. MREJ WAS DETECTED IN GENEXPERT. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23476201 ↗MalfunctionNov 5, 2025False Negative Result; False Negative Result
REPORT 2 OF 10: IT WAS REPORTED THAT DURING USE OF BD MAX¿ STAPHSR, A MREJ FALSE NEGATIVE RESULT WAS OBTAINED. MREJ WAS DETECTED IN GENEXPERT. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23476194 ↗MalfunctionNov 5, 2025False Negative Result; False Negative Result
REPORT 3 OF 10: IT WAS REPORTED THAT DURING USE OF BD MAX¿ STAPHSR, A MREJ FALSE NEGATIVE RESULT WAS OBTAINED. MREJ WAS DETECTED IN GENEXPERT. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23476193 ↗MalfunctionNov 5, 2025False Negative Result; False Negative Result
REPORT 5 OF 10: IT WAS REPORTED THAT DURING USE OF BD MAX¿ STAPHSR, A MREJ FALSE NEGATIVE RESULT WAS OBTAINED. MREJ WAS DETECTED IN GENEXPERT. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23476192 ↗MalfunctionNov 5, 2025False Negative Result; False Negative Result
REPORT 1 OF 10: IT WAS REPORTED THAT DURING USE OF BD MAX¿ STAPHSR, A MREJ FALSE NEGATIVE RESULT WAS OBTAINED. MREJ WAS DETECTED IN GENEXPERT. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23476185 ↗MalfunctionOct 28, 2025False Negative Result; False Negative Result
REPORT 1 OF 3: IT WAS REPORTED THAT DURING USE OF BD MAX¿ STAPHSR, A MREJ FALSE NEGATIVE RESULT WAS OBTAINED. MREJ WAS DETECTED IN GENEXPERT. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23406165 ↗MalfunctionOct 28, 2025False Negative Result; False Negative Result
REPORT 3 OF 3: IT WAS REPORTED THAT DURING USE OF BD MAX¿ STAPHSR, A MREJ FALSE NEGATIVE RESULT WAS OBTAINED. MREJ WAS DETECTED IN GENEXPERT. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23405824 ↗MalfunctionOct 28, 2025False Negative Result; False Negative Result
REPORT 2 OF 3: IT WAS REPORTED THAT DURING USE OF BD MAX¿ STAPHSR, A MREJ FALSE NEGATIVE RESULT WAS OBTAINED. MREJ WAS DETECTED IN GENEXPERT. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23405822 ↗MalfunctionOct 28, 2025False Negative Result; False Negative Result
REPORT 2 OF 3: IT WAS REPORTED THAT DURING USE OF BD MAX¿ STAPHSR, A MREJ FALSE NEGATIVE RESULT WAS OBTAINED. MREJ WAS DETECTED IN GENEXPERT. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23405646 ↗MalfunctionOct 28, 2025False Negative Result; False Negative Result
REPORT 3 OF 3: IT WAS REPORTED THAT DURING USE OF BD MAX¿ STAPHSR, A MREJ FALSE NEGATIVE RESULT WAS OBTAINED. MREJ WAS DETECTED IN GENEXPERT. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23405643 ↗MalfunctionOct 21, 2025False Positive Result; Incorrect, Inadequate or Imprecise Result or Readings; False Positive Result; Incorrect, Inadequate or Imprecise Result or Readings
REPORT 7 OF 10: IT WAS REPORTED THAT DURING USE OF BD MAX¿ STAPHSR, A DISCREPANT PATIENT RESULT WAS OBTAINED. SAMPLE WAS TESTED ON GENEXPERT AND MAX RESULT WAS NOT CONFIRMED. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23351776 ↗MalfunctionOct 21, 2025False Positive Result; Incorrect, Inadequate or Imprecise Result or Readings; False Positive Result; Incorrect, Inadequate or Imprecise Result or Readings
REPORT 4 OF 10: IT WAS REPORTED THAT DURING USE OF BD MAX¿ STAPHSR, A DISCREPANT PATIENT RESULT WAS OBTAINED. SAMPLE WAS TESTED ON GENEXPERT AND MAX RESULT WAS NOT CONFIRMED. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23351770 ↗MalfunctionOct 21, 2025False Positive Result; Incorrect, Inadequate or Imprecise Result or Readings; False Positive Result; Incorrect, Inadequate or Imprecise Result or Readings
REPORT 10 OF 10: IT WAS REPORTED THAT DURING USE OF BD MAX¿ STAPHSR, A DISCREPANT PATIENT RESULT WAS OBTAINED. SAMPLE WAS TESTED ON GENEXPERT AND MAX RESULT WAS NOT CONFIRMED. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23350794 ↗MalfunctionOct 21, 2025False Positive Result; Incorrect, Inadequate or Imprecise Result or Readings; False Positive Result; Incorrect, Inadequate or Imprecise Result or Readings
REPORT 8 OF 10: IT WAS REPORTED THAT DURING USE OF BD MAX¿ STAPHSR, A DISCREPANT PATIENT RESULT WAS OBTAINED. SAMPLE WAS TESTED ON GENEXPERT AND MAX RESULT WAS NOT CONFIRMED. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23350779 ↗MalfunctionOct 21, 2025False Positive Result; Incorrect, Inadequate or Imprecise Result or Readings; False Positive Result; Incorrect, Inadequate or Imprecise Result or Readings
REPORT 9 OF 10: IT WAS REPORTED THAT DURING USE OF BD MAX¿ STAPHSR, A DISCREPANT PATIENT RESULT WAS OBTAINED. SAMPLE WAS TESTED ON GENEXPERT AND MAX RESULT WAS NOT CONFIRMED. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23350775 ↗MalfunctionOct 21, 2025False Positive Result; Incorrect, Inadequate or Imprecise Result or Readings; False Positive Result; Incorrect, Inadequate or Imprecise Result or Readings
REPORT 2 OF 10: IT WAS REPORTED THAT DURING USE OF BD MAX¿ STAPHSR, A DISCREPANT PATIENT RESULT WAS OBTAINED. SAMPLE WAS TESTED ON GENEXPERT AND MAX RESULT WAS NOT CONFIRMED. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23350496 ↗MalfunctionOct 21, 2025False Positive Result; Incorrect, Inadequate or Imprecise Result or Readings; False Positive Result; Incorrect, Inadequate or Imprecise Result or Readings
REPORT 5 OF 10: IT WAS REPORTED THAT DURING USE OF BD MAX¿ STAPHSR, A DISCREPANT PATIENT RESULT WAS OBTAINED. SAMPLE WAS TESTED ON GENEXPERT AND MAX RESULT WAS NOT CONFIRMED. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23350488 ↗MalfunctionOct 21, 2025False Positive Result; Incorrect, Inadequate or Imprecise Result or Readings; False Positive Result; Incorrect, Inadequate or Imprecise Result or Readings
REPORT 3 OF 10: IT WAS REPORTED THAT DURING USE OF BD MAX¿ STAPHSR, A DISCREPANT PATIENT RESULT WAS OBTAINED. SAMPLE WAS TESTED ON GENEXPERT AND MAX RESULT WAS NOT CONFIRMED. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23350483 ↗MalfunctionOct 21, 2025False Positive Result; Incorrect, Inadequate or Imprecise Result or Readings; False Positive Result; Incorrect, Inadequate or Imprecise Result or Readings
REPORT 1 OF 10: IT WAS REPORTED THAT DURING USE OF BD MAX¿ STAPHSR, A DISCREPANT PATIENT RESULT WAS OBTAINED. SAMPLE WAS TESTED ON GENEXPERT AND MAX RESULT WAS NOT CONFIRMED. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23350482 ↗MalfunctionOct 21, 2025False Positive Result; Incorrect, Inadequate or Imprecise Result or Readings; False Positive Result; Incorrect, Inadequate or Imprecise Result or Readings
REPORT 6 OF 10: IT WAS REPORTED THAT DURING USE OF BD MAX¿ STAPHSR, A DISCREPANT PATIENT RESULT WAS OBTAINED. SAMPLE WAS TESTED ON GENEXPERT AND MAX RESULT WAS NOT CONFIRMED. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23350481 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.