BD MAX™ System 441916Recalls & reported problems
Becton, Dickinson And Company · Instrument Max Clinical · Class 2
2 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This BD MAX System is a lab instrument that runs real-time tests to detect genetic material in patient samples. Of its 1,119 reports, 6 describe injuries and 1,113 describe malfunctions, with no deaths. Most reports describe false positive results, along with other inaccurate results. Reports rose to 203 in the last 12 months from 138 in the previous 12 months. 2 open recalls concern support login credentials accessed by an unauthorized person.
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
- 1,109
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls naming it
- 2
Summary
The FDA's MAUDE database contains 1,109 adverse event reports that list this exact device (DI 00382904419165), received between Oct 22, 2019 and Sep 30, 2026 — classified as 6 injuries, 1,103 malfunctions.
The most frequently reported specific device problem is “False Positive Result” (753 reports).
2 FDA recall records name this device's identifier, 2 still open.
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
- Sep 23, 2025Open, Classified
Product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product service credentials are updated, there is a risk of unauthorized access that may impact the confidentiality, integrity and/or availability of the relevant products and associated data.
Z-0238-2026 · Root cause: Software design · FDA record ↗
- Oct 31, 2024Open, Classified
BD confirmed that product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product service credentials are updated, there is a risk of unauthorized access that may impact the confidentiality, integrity and/or availability of the relevant products and associated data.
Z-0590-2025 · Root cause: Software design · FDA record ↗
Most reported problems
Device problems
- False Positive Result753
- Incorrect, Inadequate or Imprecise Result or Readings249
- Structural Problem47
- False Negative Result40
- Nonstandard Device3
- Device Fell2
- Mechanical Problem2
- Non Reproducible Results2
Patient problems
- No Clinical Signs, Symptoms or Conditions1,024
- No Consequences Or Impact To Patient105
- No Patient Involvement15
- No Known Impact Or Consequence To Patient12
- Test Result2
- Discomfort1
- Insufficient Information1
- No Information1
Recent adverse event reports
The 25 most recent of 1,109 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Nonstandard Device
It was reported that during use of the BD MAX System, BD MAX Instrument, the door would not remain open. No injuries were reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50950930 ↗MalfunctionSep 25, 2026False Positive Result
It was reported that during use of BD MAX¿ System, BD MAX¿ Instrument, a False Positive patient result was obtained. There was no report of patient impact.Assay used: Enteric parasite panel
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50900329 ↗MalfunctionSep 25, 2026False Positive Result
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50899379 ↗MalfunctionSep 25, 2026False Positive Result
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50899351 ↗MalfunctionSep 25, 2026Incorrect, Inadequate or Imprecise Result or Readings
It was reported that during use of BD MAX¿ System, BD MAX¿ Instrument, a patient TB result was falsely resistant to isoniazid. There was no report of patient impact.Assay used: TB.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50897361 ↗MalfunctionSep 23, 2026False Positive Result
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50873315 ↗MalfunctionSep 23, 2026False Positive Result
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50873313 ↗MalfunctionSep 23, 2026False Positive Result
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50873311 ↗MalfunctionSep 23, 2026False Positive Result
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50873297 ↗MalfunctionSep 23, 2026False Positive Result
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50873296 ↗MalfunctionSep 23, 2026False Positive Result
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50873012 ↗MalfunctionSep 23, 2026False Positive Result
It was reported that during use of BD MAX¿ System, BD MAX¿ Instrument, a False Positive patient result for C. diff was obtained. There was no report of patient impact.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50870540 ↗MalfunctionSep 23, 2026False Positive Result
It was reported that during use of BD MAX¿ System, BD MAX¿ Instrument, a False Positive patient result for C. diff was obtained. There was no report of patient impact.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50870538 ↗MalfunctionSep 23, 2026False Positive Result
It was reported that during use of BD MAX¿ System, BD MAX¿ Instrument, a False Positive patient result for C. diff was obtained. There was no report of patient impact.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50870511 ↗MalfunctionSep 17, 2026False Positive Result
It was reported that during use of BD MAX¿ System, BD MAX¿ Instrument, a False Positive patient result was obtained. There was no report of patient impact.Assay used: Extended Enteric Bacterial panel.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50806101 ↗MalfunctionSep 17, 2026False Positive Result
It was reported that during use of BD MAX¿ System, BD MAX¿ Instrument, a False Positive patient result was obtained. There was no report of patient impact.Assay used: Extended Enteric Bacterial panel
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50806100 ↗MalfunctionSep 17, 2026False Positive Result
It was reported that during use of BD MAX¿ System, BD MAX¿ Instrument, a False Positive patient result was obtained. There was no report of patient impact.Assay used: Extended Enteric Bacterial panel.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50806098 ↗MalfunctionAug 28, 2026False Positive Result
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50508415 ↗MalfunctionAug 28, 2026False Positive Result
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50508413 ↗MalfunctionAug 28, 2026False Positive Result
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50508412 ↗MalfunctionAug 28, 2026False Positive Result
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50508411 ↗MalfunctionAug 28, 2026False Positive Result
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50508409 ↗MalfunctionAug 28, 2026False Positive Result
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50508405 ↗MalfunctionAug 28, 2026False Positive Result
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50508404 ↗MalfunctionAug 28, 2026False Positive Result
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50508403 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.