BD Phoenix™ AST Broth 4.5 mL 246011Recalls & reported problems
Becton, Dickinson And Company · BD Phoenix™ AST Broth 4.5 mL · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This BD Phoenix AST broth is a laboratory reagent used for automated antimicrobial susceptibility testing. Reports mostly describe biological contamination, labeling problems, and inaccurate or inadequate readings. There are 42 reports, with no deaths or injuries; no recalls name this device. Reports rose from 0 in the previous 12 months to 18 in the most recent 12 months.
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
- 42
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 42 adverse event reports that list this exact device (DI 30382902460115), received between Mar 16, 2021 and Apr 17, 2026 — classified as 42 malfunctions.
The most frequently reported specific device problem is “Device Markings/Labelling Problem” (20 reports).
4 other recalls cover devices cleared under the same FDA submission (K020321); 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
Most reported problems
Device problems
- Device Markings/Labelling Problem20
- Incorrect, Inadequate or Imprecise Result or Readings19
- Contamination1
- Contamination of Device Ingredient or Reagent1
- Missing Information1
Patient problems
- No Clinical Signs, Symptoms or Conditions42
Recent adverse event reports
The 25 most recent of 42 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 17, 2026Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED WHILE USING THE BD PHOENIX¿ AST BROTH BIOLOGICAL CONTAMINATION IS NOTED WITHIN THE BROTH. NO HEALTH IMPACT OR CONSEQUENCE REPORTED. THIS IS REPORT 17 OF 18.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24913318 ↗MalfunctionApr 17, 2026Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED WHILE USING THE BD PHOENIX¿ AST BROTH BIOLOGICAL CONTAMINATION IS NOTED WITHIN THE BROTH. NO HEALTH IMPACT OR CONSEQUENCE REPORTED. THIS IS REPORT 18 OF 18.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24913317 ↗MalfunctionApr 17, 2026Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED WHILE USING THE BD PHOENIX¿ AST BROTH BIOLOGICAL CONTAMINATION IS NOTED WITHIN THE BROTH. NO HEALTH IMPACT OR CONSEQUENCE REPORTED. THIS IS REPORT 14 OF 18.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24913314 ↗MalfunctionApr 17, 2026Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED WHILE USING THE BD PHOENIX¿ AST BROTH BIOLOGICAL CONTAMINATION IS NOTED WITHIN THE BROTH. NO HEALTH IMPACT OR CONSEQUENCE REPORTED. THIS IS REPORT 13 OF 18.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24913313 ↗MalfunctionApr 17, 2026Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED WHILE USING THE BD PHOENIX¿ AST BROTH BIOLOGICAL CONTAMINATION IS NOTED WITHIN THE BROTH. NO HEALTH IMPACT OR CONSEQUENCE REPORTED. THIS IS REPORT 11 OF 18.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24913312 ↗MalfunctionApr 17, 2026Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED WHILE USING THE BD PHOENIX¿ AST BROTH BIOLOGICAL CONTAMINATION IS NOTED WITHIN THE BROTH. NO HEALTH IMPACT OR CONSEQUENCE REPORTED. THIS IS REPORT 10 OF 18.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24913311 ↗MalfunctionApr 17, 2026Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED WHILE USING THE BD PHOENIX¿ AST BROTH BIOLOGICAL CONTAMINATION IS NOTED WITHIN THE BROTH. NO HEALTH IMPACT OR CONSEQUENCE REPORTED. THIS IS REPORT 16 OF 18.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24913310 ↗MalfunctionApr 17, 2026Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED WHILE USING THE BD PHOENIX¿ AST BROTH BIOLOGICAL CONTAMINATION IS NOTED WITHIN THE BROTH. NO HEALTH IMPACT OR CONSEQUENCE REPORTED. THIS IS REPORT 15 OF 18.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24913309 ↗MalfunctionApr 17, 2026Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED WHILE USING THE BD PHOENIX¿ AST BROTH BIOLOGICAL CONTAMINATION IS NOTED WITHIN THE BROTH. NO HEALTH IMPACT OR CONSEQUENCE REPORTED. THIS IS REPORT 12 OF 18.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24913308 ↗MalfunctionApr 17, 2026Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED WHILE USING THE BD PHOENIX¿ AST BROTH BIOLOGICAL CONTAMINATION IS NOTED WITHIN THE BROTH. NO HEALTH IMPACT OR CONSEQUENCE REPORTED. THIS IS REPORT 7 OF 18.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24913307 ↗MalfunctionApr 17, 2026Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED WHILE USING THE BD PHOENIX¿ AST BROTH BIOLOGICAL CONTAMINATION IS NOTED WITHIN THE BROTH. NO HEALTH IMPACT OR CONSEQUENCE REPORTED. THIS IS REPORT 5 OF 18.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24913305 ↗MalfunctionApr 17, 2026Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED WHILE USING THE BD PHOENIX¿ AST BROTH BIOLOGICAL CONTAMINATION IS NOTED WITHIN THE BROTH. NO HEALTH IMPACT OR CONSEQUENCE REPORTED. THIS IS REPORT 4 OF 18.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24913304 ↗MalfunctionApr 17, 2026Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED WHILE USING THE BD PHOENIX¿ AST BROTH BIOLOGICAL CONTAMINATION IS NOTED WITHIN THE BROTH. NO HEALTH IMPACT OR CONSEQUENCE REPORTED. THIS IS REPORT 8 OF 18.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24913303 ↗MalfunctionApr 17, 2026Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED WHILE USING THE BD PHOENIX¿ AST BROTH BIOLOGICAL CONTAMINATION IS NOTED WITHIN THE BROTH. NO HEALTH IMPACT OR CONSEQUENCE REPORTED. THIS IS REPORT 9 OF 18.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24913302 ↗MalfunctionApr 17, 2026Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED WHILE USING THE BD PHOENIX¿ AST BROTH BIOLOGICAL CONTAMINATION IS NOTED WITHIN THE BROTH. NO HEALTH IMPACT OR CONSEQUENCE REPORTED. THIS IS REPORT 6 OF 18.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24913301 ↗MalfunctionApr 17, 2026Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED WHILE USING THE BD PHOENIX¿ AST BROTH BIOLOGICAL CONTAMINATION IS NOTED WITHIN THE BROTH. NO HEALTH IMPACT OR CONSEQUENCE REPORTED. THIS IS REPORT 2 OF 18.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24913299 ↗MalfunctionApr 17, 2026Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED WHILE USING THE BD PHOENIX¿ AST BROTH BIOLOGICAL CONTAMINATION IS NOTED WITHIN THE BROTH. NO HEALTH IMPACT OR CONSEQUENCE REPORTED. THIS IS REPORT 3 OF 18.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24913297 ↗MalfunctionApr 17, 2026Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED WHILE USING THE BD PHOENIX¿ AST BROTH BIOLOGICAL CONTAMINATION IS NOTED WITHIN THE BROTH. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24912294 ↗MalfunctionOct 24, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem
IT WAS REPORTED WHILE USING THE BD PHOENIX AST BROTH 4.5 ML A PATIENT SAMPLE HAD AN INVALID RESULT DUE TO THE PRODUCT BEING MIX WITH ANOTHER WITHIN THE SHELF PACKAGING. ALL OF THE PATIENT TESTING NEEDED TO BE REPEATED. NO HEALTH IMPACT OR CONSEQUENCE REPORTED. REPORT 7 OF 21.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20522218 ↗MalfunctionOct 23, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem
IT WAS REPORTED WHILE USING THE BD PHOENIX AST BROTH 4.5 ML A PATIENT SAMPLE HAD AN INVALID RESULT DUE TO THE PRODUCT BEING MIX WITH ANOTHER WITHIN THE SHELF PACKAGING. ALL OF THE PATIENT TESTING NEEDED TO BE REPEATED. NO HEALTH IMPACT OR CONSEQUENCE REPORTED. REPORT 20 OF 21.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20517182 ↗MalfunctionOct 23, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem
IT WAS REPORTED WHILE USING THE BD PHOENIX AST BROTH 4.5 ML A PATIENT SAMPLE HAD AN INVALID RESULT DUE TO THE PRODUCT BEING MIX WITH ANOTHER WITHIN THE SHELF PACKAGING. ALL OF THE PATIENT TESTING NEEDED TO BE REPEATED. NO HEALTH IMPACT OR CONSEQUENCE REPORTED. REPORT 11 OF 21.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20516937 ↗MalfunctionOct 23, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem
IT WAS REPORTED WHILE USING THE BD PHOENIX AST BROTH 4.5 ML A PATIENT SAMPLE HAD AN INVALID RESULT DUE TO THE PRODUCT BEING MIX WITH ANOTHER WITHIN THE SHELF PACKAGING. ALL OF THE PATIENT TESTING NEEDED TO BE REPEATED. NO HEALTH IMPACT OR CONSEQUENCE REPORTED. REPORT 16 OF 21.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20516869 ↗MalfunctionOct 23, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem
IT WAS REPORTED WHILE USING THE BD PHOENIX AST BROTH 4.5 ML A PATIENT SAMPLE HAD AN INVALID RESULT DUE TO THE PRODUCT BEING MIX WITH ANOTHER WITHIN THE SHELF PACKAGING. ALL OF THE PATIENT TESTING NEEDED TO BE REPEATED. NO HEALTH IMPACT OR CONSEQUENCE REPORTED. REPORT 18 OF 21.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20516769 ↗MalfunctionOct 23, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem
IT WAS REPORTED WHILE USING THE BD PHOENIX AST BROTH 4.5 ML A PATIENT SAMPLE HAD AN INVALID RESULT DUE TO THE PRODUCT BEING MIX WITH ANOTHER WITHIN THE SHELF PACKAGING. ALL OF THE PATIENT TESTING NEEDED TO BE REPEATED. NO HEALTH IMPACT OR CONSEQUENCE REPORTED. REPORT 14 OF 21.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20516617 ↗MalfunctionOct 23, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem
IT WAS REPORTED WHILE USING THE BD PHOENIX AST BROTH 4.5 ML A PATIENT SAMPLE HAD AN INVALID RESULT DUE TO THE PRODUCT BEING MIX WITH ANOTHER WITHIN THE SHELF PACKAGING. ALL OF THE PATIENT TESTING NEEDED TO BE REPEATED. NO HEALTH IMPACT OR CONSEQUENCE REPORTED. REPORT 6 OF 21.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20516241 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K020321. One submission often covers many models, so check the product and lot details in each record.
- Z-0239-2026 · Sep 23, 2025 · Open, ClassifiedBD Phoenix M50 Instrument, labeled as the following: 1. BD Phoenix M50 Automated Microbiology System, Catalog Numbers: 443624, 44362409.
- Z-0592-2025 · Oct 31, 2024 · Open, ClassifiedBD Phoenix M50 Automated Microbiology System Version or Model: 443624 Catalog Number: 443624
- Z-3246-2024 · Aug 1, 2024 · Open, ClassifiedBD Phoenix M50 instrument -Intended for the rapid identification (ID) and antimicrobial susceptibility testing (AST) of clinically significant bacteria. The BD Phoenix System provi
- 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
Other SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION devices
- BD Phoenix™ M50 Automated Microbiology System 443624Becton, Dickinson And Company · SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION3 recalls417 reports
- 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
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
- 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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