BD Phoenix™ M50 Automated Microbiology System 443624Recalls & reported problems
Becton, Dickinson And Company · BD Phoenix™ M50 Automated Microbiology System · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
3 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This BD Phoenix M50 microbiology system has 424 reports, including 1 injury and no deaths. Most reports describe incorrect, imprecise or inaccurate test results. 3 open recalls: two concern service login credentials that an unauthorized person accessed, creating a risk to the system's data and operation, and one concerns Escherichia coli being misidentified in clinical samples, which may lead to wrong diagnosis and treatment.
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
- 417
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 3
Summary
The FDA's MAUDE database contains 417 adverse event reports that list this exact device (DI 00382904436247), received between Feb 4, 2021 and Sep 29, 2026 — classified as 1 injury, 416 malfunctions.
The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (319 reports).
3 FDA recall records name this device's identifier, 3 still open.
1 other recall cover devices cleared under the same FDA submission (K020321, K040099, K131331, K250344); they may or may not involve this specific model.
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.
Reports received per month
Recalls naming this device
- Sep 23, 2025Class IIOpen, 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-0239-2026 · Root cause: Software design · Recall details · FDA record ↗
- Oct 31, 2024Class IIOpen, 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-0592-2025 · Root cause: Software design · Recall details · FDA record ↗
- Aug 1, 2024Class IIOpen, Classified
Escherichia coli (E. coli) misidentification for clinical samples that were tested on BD Phoenix" M50 instrument and BD Phoenix" 100, may lead to misdiagnosis and inappropriate treatment of infections caused by E. coli,
Z-3246-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported problems
Device problems
- Incorrect, Inadequate or Imprecise Result or Readings319
- Incorrect Measurement99
- False Positive Result6
- Cross Reactivity1
- Patient Data Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions412
- Insufficient Information3
- No Consequences Or Impact To Patient3
Recent adverse event reports
The 25 most recent of 417 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Incorrect Measurement
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50939013 ↗MalfunctionSep 28, 2026Incorrect Measurement
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50923606 ↗MalfunctionSep 17, 2026Incorrect Measurement
It was reported while using the BD Phoenix¿ M50 Automated Microbiology System an unspecified number of patient isolates, gram-negative Escherichia coli, gram positive Staphylococcus epidermidis and Staphylococcus capitis were misidentified as Shigella spp. and Staphylococcus aureus. The user verified the final result using repeat testing and bacterial culture. No health impact or consequence reported.This is report 2 of 3.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50803125 ↗MalfunctionSep 17, 2026Incorrect Measurement
It was reported while using the BD Phoenix¿ M50 Automated Microbiology System an unspecified number of patient isolates, gram-negative Escherichia coli, gram positive Staphylococcus epidermidis and Staphylococcus capitis were misidentified as Shigella spp. and Staphylococcus aureus. The user verified the final result using repeat testing and bacterial culture. No health impact or consequence reported.This is report 3 of 3.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50803123 ↗MalfunctionSep 16, 2026Incorrect Measurement
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50794637 ↗MalfunctionSep 15, 2026Incorrect Measurement
It was reported while using the BD Phoenix¿ M50 Automated Microbiology System a patient isolate (Staphylococcus aureus) was misidentified as Staphylococcus epidermidis. The user verified the final result using bacterial culture. No health impact or consequence reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50773761 ↗MalfunctionAug 28, 2026Incorrect Measurement
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50506883 ↗MalfunctionAug 19, 2026Incorrect Measurement
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50324125 ↗MalfunctionAug 19, 2026Incorrect Measurement
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50324120 ↗MalfunctionAug 19, 2026Incorrect Measurement
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50321236 ↗MalfunctionAug 19, 2026Incorrect Measurement
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50321230 ↗MalfunctionAug 18, 2026Incorrect Measurement
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50303790 ↗MalfunctionAug 12, 2026Incorrect Measurement
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50222599 ↗MalfunctionAug 11, 2026Incorrect Measurement
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50209946 ↗MalfunctionJul 31, 2026Incorrect Measurement
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50105803 ↗MalfunctionJul 31, 2026Incorrect Measurement
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50105802 ↗MalfunctionJul 31, 2026Incorrect Measurement
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50099471 ↗MalfunctionJul 30, 2026Incorrect Measurement
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50084423 ↗MalfunctionJul 21, 2026Incorrect Measurement
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25893097 ↗MalfunctionJul 21, 2026Incorrect Measurement
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25892162 ↗MalfunctionJul 21, 2026Incorrect Measurement
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25892143 ↗MalfunctionJul 21, 2026Incorrect Measurement
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25889295 ↗MalfunctionJul 21, 2026Incorrect Measurement
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25889063 ↗MalfunctionJul 9, 2026Incorrect Measurement
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25764166 ↗MalfunctionJun 8, 2026Incorrect Measurement
IT WAS REPORTED WHILE USING THE BD PHOENIX¿ M50 AUTOMATED MICROBIOLOGY SYSTEM AN UNSPECIFIED NUMBER OF PATIENT ISOLATES HAD INCONSISTENT RESULTS. THE USER EXPECTED STAPHYLOCOCCUS SAPROPHYTICUS BUT OBTAINED STAPHYLOCOCCUS INTERMEDIUS. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25427848 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K020321, K040099, K131331, K250344. One submission often covers many models, so check the product and lot details in each record.
- Z-3247-2024 · Aug 1, 2024 · Open, ClassifiedBD Phoenix 100-Intended for the rapid identification (ID) and antimicrobial susceptibility testing (AST) of clinically significant bacteria. The BD Phoenix System provides rapid re
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- BD Phoenix™ NMIC/ID-307 449289Becton, Dickinson And Company · SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION529 reports
- BD Phoenix™ PMIC/ID-107 448607Becton, Dickinson And Company · SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION2 recalls169 reports
- BD Phoenix™ NMIC-306 449292Becton, Dickinson And Company · SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION1 recall143 reports
- VITEK® 2 AST-GP67Biomerieux , Inc. · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation2 recalls83 reports
- BD Phoenix™ AST Broth 246003Becton, Dickinson And Company · SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION182 reports
- VITEK® 2 AST-GP75Biomerieux , Inc. · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation2 recalls52 reports
- VITEK® 2 AST-GP78Biomerieux , Inc. · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation2 recalls41 reports
- VITEK® 2 AST-GN99Biomerieux , Inc. · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation2 recalls2 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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