BD Phoenix™ NMIC-311 449452Recalls & reported problems
Becton, Dickinson And Company · BD Phoenix™ NMIC-311 · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This BD Phoenix NMIC-311 is an automated system that tests how quickly bacteria in a patient sample grow, so labs can see which antibiotics work. The 55 reports mostly describe the system reading certain carbapenem antibiotics, such as ertapenem, meropenem and imipenem, as resistant when the bacteria were actually sensitive, which labs confirmed by repeat testing or other methods. No deaths and no injuries were reported, and no recalls name this device.
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
- 56
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 56 adverse event reports that list this exact device (DI 30382904494521), received between Oct 25, 2023 and Sep 30, 2026 — classified as 56 malfunctions.
The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (45 reports).
2 other recalls cover devices cleared under the same FDA submission (K020322, K022129, K023444, K023634, K023858, K024153, K031530, K031699, K031912, K032299, K032567, K032655, K033362, K033458, K033560, K041384, K042932, K052269, K060214, K060217, K060257, K060444, K060447, K061327, K061355, K062207, K062944, K063301, K063486, K063573, K063811, K063824, K071623, K123266, K123404, K132674, K132909, K151320, K163637, K173252, K173523, K190905); 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Incorrect, Inadequate or Imprecise Result or Readings45
- False Positive Result11
Patient problems
- No Clinical Signs, Symptoms or Conditions56
Recent adverse event reports
The 25 most recent of 56 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Incorrect, Inadequate or Imprecise Result or Readings
It was reported while using the Panel Phoenix NMIC-311 an unknown number of patient isolates had a low MIC (false susceptible) result for the drug Aztreonam, but confirmatory testing had a resistant result. The user stated that some patients had treatment changes and were put in isolation. No health impact or consequence reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50945870 ↗MalfunctionFeb 19, 2026Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED WHILE USING THE BD PHOENIX¿ NMIC-311 A PATIENT ISOLATE (KLEBSIELLA VARIICOLA) HAD FALSE RESISTANCE (HIGH MIC) WITH THE DRUGS ERTAPENEM AND MEROPENEM. THE USER VERIFIED THE FINAL RESULT USING KIRBY BAUER STATING THAT THE ISOLATE IS SENSITIVE TO BOTH DRUGS. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24389360 ↗MalfunctionFeb 19, 2026Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED WHILE USING THE BD PHOENIX¿ NMIC-311 A PATIENT ISOLATE (KLEBSIELLA PNEUMONIAE) HAD FALSE RESISTANCE (HIGH MIC) WITH THE DRUGS ERTAPENEM AND MEROPENEM. THE USER VERIFIED THE FINAL RESULT USING KIRBY BAUER STATING THAT THE ISOLATE IS SENSITIVE TO BOTH DRUGS. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24389358 ↗MalfunctionFeb 19, 2026Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED WHILE USING THE BD PHOENIX¿ NMIC-311 A PATIENT ISOLATE (ESCHERICHIA COLI) HAD FALSE RESISTANCE (HIGH MIC) WITH THE DRUG ERTAPENEM. THE USER STATED AN OVERALL INCREASE IN CARBAPENEM-RESISTANT ENTEROBACTERALES (CRE). THE USER VERIFIED THE FINAL RESULT USING REPEAT TESTING STATING THAT THE ISOLATE IS SENSITIVE. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24388365 ↗MalfunctionFeb 19, 2026Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED WHILE USING THE BD PHOENIX¿ NMIC-311 A PATIENT ISOLATE (KLEBSIELLA PNEUMONIAE) HAD FALSE RESISTANCE (HIGH MIC) WITH THE DRUGS ERTAPENEM AND MEROPENEM. THE USER STATED AN OVERALL INCREASE IN CARBAPENEM-RESISTANT ENTEROBACTERALES (CRE). THE USER VERIFIED THE FINAL RESULT USING REPEAT TESTING STATING THAT THE ISOLATE IS SENSITIVE. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24388363 ↗MalfunctionFeb 19, 2026Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED WHILE USING THE BD PHOENIX¿ NMIC-311 A PATIENT ISOLATE (ESCHERICHIA COLI) HAD FALSE RESISTANCE (HIGH MIC) WITH THE DRUG ERTAPENEM. THE USER STATED AN OVERALL INCREASE IN CARBAPENEM-RESISTANT ENTEROBACTERALES (CRE). THE USER VERIFIED THE FINAL RESULT USING REPEAT TESTING STATING THAT THE ISOLATE IS SENSITIVE. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24388335 ↗MalfunctionFeb 17, 2026Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED WHILE USING THE BD PHOENIX¿ NMIC-311 PATIENT ISOLATES ENTEROBACTER CLOACAE COMPLEX, ESCHERICHIA COLI, AND KLEBSIELLA PNEUMONIAE HAVE HIGH MIC (FALSE RESISTANT) RESULTS FOR THE DRUGS ERTAPENEM, MEROPENEM, AND IMIPENEM. THE USER STATED THERE HAS BEEN AN INCREASE IN CARBAPENEM-RESISTANT ENTEROBACTERALES (CRE) RATES. NO HEALTH IMPACT OR CONSEQUENCE REPORTED. THIS IS REPORT 2 OF 6.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24368852 ↗MalfunctionFeb 17, 2026Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED WHILE USING THE BD PHOENIX¿ NMIC-311 PATIENT ISOLATES ENTEROBACTER CLOACAE COMPLEX, ESCHERICHIA COLI, AND KLEBSIELLA PNEUMONIAE HAVE HIGH MIC (FALSE RESISTANT) RESULTS FOR THE DRUGS ERTAPENEM, MEROPENEM, AND IMIPENEM. THE USER STATED THERE HAS BEEN AN INCREASE IN CARBAPENEM-RESISTANT ENTEROBACTERALES (CRE) RATES. NO HEALTH IMPACT OR CONSEQUENCE REPORTED. THIS IS REPORT 6 OF 6.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24368849 ↗MalfunctionFeb 17, 2026Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED WHILE USING THE BD PHOENIX¿ NMIC-311 PATIENT ISOLATES ENTEROBACTER CLOACAE COMPLEX, ESCHERICHIA COLI, AND KLEBSIELLA PNEUMONIAE HAVE HIGH MIC (FALSE RESISTANT) RESULTS FOR THE DRUGS ERTAPENEM, MEROPENEM, AND IMIPENEM. THE USER STATED THERE HAS BEEN AN INCREASE IN CARBAPENEM-RESISTANT ENTEROBACTERALES (CRE) RATES. NO HEALTH IMPACT OR CONSEQUENCE REPORTED. THIS IS REPORT 5 OF 6.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24368848 ↗MalfunctionFeb 17, 2026Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED WHILE USING THE BD PHOENIX¿ NMIC-311 PATIENT ISOLATES ENTEROBACTER CLOACAE COMPLEX, ESCHERICHIA COLI, AND KLEBSIELLA PNEUMONIAE HAVE HIGH MIC (FALSE RESISTANT) RESULTS FOR THE DRUGS ERTAPENEM, MEROPENEM, AND IMIPENEM. THE USER STATED THERE HAS BEEN AN INCREASE IN CARBAPENEM-RESISTANT ENTEROBACTERALES (CRE) RATES. NO HEALTH IMPACT OR CONSEQUENCE REPORTED. THIS IS REPORT 3 OF 6.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24368847 ↗MalfunctionFeb 17, 2026Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED WHILE USING THE BD PHOENIX¿ NMIC-311 PATIENT ISOLATES ENTEROBACTER CLOACAE COMPLEX, ESCHERICHIA COLI, AND KLEBSIELLA PNEUMONIAE HAVE HIGH MIC (FALSE RESISTANT) RESULTS FOR THE DRUGS ERTAPENEM, MEROPENEM, AND IMIPENEM. THE USER STATED THERE HAS BEEN AN INCREASE IN CARBAPENEM-RESISTANT ENTEROBACTERALES (CRE) RATES. NO HEALTH IMPACT OR CONSEQUENCE REPORTED. THIS IS REPORT 4 OF 6.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24368844 ↗MalfunctionFeb 17, 2026Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED WHILE USING THE BD PHOENIX¿ NMIC-311 PATIENT ISOLATES ENTEROBACTER CLOACAE COMPLEX, ESCHERICHIA COLI, AND KLEBSIELLA PNEUMONIAE HAVE HIGH MIC (FALSE RESISTANT) RESULTS FOR THE DRUGS ERTAPENEM, MEROPENEM, AND IMIPENEM. THE USER STATED THERE HAS BEEN AN INCREASE IN CARBAPENEM-RESISTANT ENTEROBACTERALES (CRE) RATES. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24366903 ↗MalfunctionDec 18, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED WHILE USING THE BD PHOENIX¿ NMIC-311 AN UNSPECIFIED NUMBER OF PATIENT RESULTS HAD FALSE RESISTANCE WITH THE CARBAPENEM DRUG CLASS, SPECIFICALLY CARBAPENEM-RESISTANT ENTEROBACTERALES (CRE). THE USER VERIFIED THE FINAL RESULT USING REPEAT TESTING. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23842839 ↗MalfunctionAug 7, 2025False Positive Result; False Positive Result
IT WAS REPORTED WHILE USING THE BD PHOENIX¿ NMIC-311 THE USER NOTED THAT THERE WAS AN INCREASE IN EXTENDED-SPECTRUM BETA-LACTAMASE (ESBL) AND CARBAPENEM RESISTANT ISOLATES. ADDITIONALLY, THE USER NOTED QC FAILURES ASSOCIATED WITH HIGH MICS. NO HEALTH IMPACT OR CONSEQUENCE REPORTED. REPORT 3 OF 8.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22739642 ↗MalfunctionAug 7, 2025False Positive Result; False Positive Result
IT WAS REPORTED WHILE USING THE BD PHOENIX¿ NMIC-311 THE USER NOTED THAT THERE WAS AN INCREASE IN EXTENDED-SPECTRUM BETA-LACTAMASE (ESBL) AND CARBAPENEM RESISTANT ISOLATES. ADDITIONALLY, THE USER NOTED QC FAILURES ASSOCIATED WITH HIGH MICS. NO HEALTH IMPACT OR CONSEQUENCE REPORTED. REPORT 7 OF 8.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22739631 ↗MalfunctionAug 7, 2025False Positive Result; False Positive Result
IT WAS REPORTED WHILE USING THE BD PHOENIX¿ NMIC-311 THE USER NOTED THAT THERE WAS AN INCREASE IN EXTENDED-SPECTRUM BETA-LACTAMASE (ESBL) AND CARBAPENEM RESISTANT ISOLATES. ADDITIONALLY, THE USER NOTED QC FAILURES ASSOCIATED WITH HIGH MICS. NO HEALTH IMPACT OR CONSEQUENCE REPORTED. REPORT 8 OF 8.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22739627 ↗MalfunctionAug 7, 2025False Positive Result; False Positive Result
IT WAS REPORTED WHILE USING THE BD PHOENIX¿ NMIC-311 THE USER NOTED THAT THERE WAS AN INCREASE IN EXTENDED-SPECTRUM BETA-LACTAMASE (ESBL) AND CARBAPENEM RESISTANT ISOLATES. ADDITIONALLY, THE USER NOTED QC FAILURES ASSOCIATED WITH HIGH MICS. NO HEALTH IMPACT OR CONSEQUENCE REPORTED. REPORT 6 OF 8.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22739621 ↗MalfunctionAug 7, 2025False Positive Result; False Positive Result
IT WAS REPORTED WHILE USING THE BD PHOENIX¿ NMIC-311 THE USER NOTED THAT THERE WAS AN INCREASE IN EXTENDED-SPECTRUM BETA-LACTAMASE (ESBL) AND CARBAPENEM RESISTANT ISOLATES. ADDITIONALLY, THE USER NOTED QC FAILURES ASSOCIATED WITH HIGH MICS. NO HEALTH IMPACT OR CONSEQUENCE REPORTED. REPORT 2 OF 8.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22739619 ↗MalfunctionAug 7, 2025False Positive Result; False Positive Result
IT WAS REPORTED WHILE USING THE BD PHOENIX¿ NMIC-311 THE USER NOTED THAT THERE WAS AN INCREASE IN EXTENDED-SPECTRUM BETA-LACTAMASE (ESBL) AND CARBAPENEM RESISTANT ISOLATES. ADDITIONALLY, THE USER NOTED QC FAILURES ASSOCIATED WITH HIGH MICS. NO HEALTH IMPACT OR CONSEQUENCE REPORTED. REPORT 5 OF 8.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22739617 ↗MalfunctionAug 7, 2025False Positive Result; False Positive Result
IT WAS REPORTED WHILE USING THE BD PHOENIX¿ NMIC-311 THE USER NOTED THAT THERE WAS AN INCREASE IN EXTENDED-SPECTRUM BETA-LACTAMASE (ESBL) AND CARBAPENEM RESISTANT ISOLATES. ADDITIONALLY, THE USER NOTED QC FAILURES ASSOCIATED WITH HIGH MICS. NO HEALTH IMPACT OR CONSEQUENCE REPORTED. REPORT 4 OF 8.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22739611 ↗MalfunctionAug 7, 2025False Positive Result; False Positive Result
IT WAS REPORTED WHILE USING THE BD PHOENIX¿ NMIC-311 THE USER NOTED THAT THERE WAS AN INCREASE IN EXTENDED-SPECTRUM BETA-LACTAMASE (ESBL) AND CARBAPENEM RESISTANT ISOLATES. ADDITIONALLY, THE USER NOTED QC FAILURES ASSOCIATED WITH HIGH MICS. NO HEALTH IMPACT OR CONSEQUENCE REPORTED. REPORT 1 OF 8.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22738555 ↗MalfunctionFeb 18, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED WHILE USING THE BD PHOENIX¿ NMIC-311 THAT AN UNSPECIFIED NUMBER OF PATIENT ISOLATES HAD AN INCREASE IN EXTENDED-SPECTRUM BETA-LACTAMASES (ESBL) RESISTANCE. THE USER NOTED THAT UPON REPEAT THE RESISTANT ISOLATES WERE SENSITIVE. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21399376 ↗MalfunctionDec 13, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED WHILE USING THE BD PHOENIX¿ NMIC-311 A PATIENT ISOLATE (ESCHERICHIA COLI) HAD A HIGH MIC (FALSE RESISTANCE) FOR THE DRUG IMIPENEM BUT WHEN REPEATED IT WAS SENSITIVE. THE USER ALSO NOTED THAT THE DRUG ERTAPENEM PERIODICALLY GAVE HIGH MICS. NO HEALTH IMPACT OR CONSEQUENCE REPORTED. REPORT 2 OF 2.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20925385 ↗MalfunctionDec 13, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED WHILE USING THE BD PHOENIX¿ NMIC-311 A PATIENT ISOLATE (KLEBSIELLA PNEUMONIAE) HAD A HIGH MIC (FALSE RESISTANCE) FOR THE DRUG IMIPENEM BUT WHEN REPEATED IT WAS SENSITIVE. THE USER ALSO NOTED THAT THE DRUG ERTAPENEM PERIODICALLY GAVE HIGH MICS. NO HEALTH IMPACT OR CONSEQUENCE REPORTED. REPORT 1 OF 2.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20925349 ↗MalfunctionNov 21, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED WHILE USING THE BD PHOENIX¿ NMIC-311 AN UNSPECIFIED NUMBER OF PATIENT ISOLATES HAD HIGH MICS (FALSE RESISTANCES) FOR CARBAPENEMS. THE USER NOTED THAT SPECIFIC DRUGS LIKE, ERTAPENEM AND MEROPENEM, ARE RESISTANT BUT ARE NOT WITH REPEAT TESTING. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20745702 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K020322, K022129, K023444, K023634, K023858, K024153, K031530, K031699, K031912, K032299, K032567, K032655, K033362, K033458, K033560, K041384, K042932, K052269, K060214, K060217, K060257, K060444, K060447, K061327, K061355, K062207, K062944, K063301, K063486, K063573, K063811, K063824, K071623, K123266, K123404, K132674, K132909, K151320, K163637, K173252, K173523, K190905. One submission often covers many models, so check the product and lot details in each record.
- Z-1398-2024 · Feb 29, 2024 · Open, ClassifiedBD Phoenix NMIC-306 Panel is a self-inoculating (when used with a BD Phoenix Automated Microbiology System) polystyrene panel (tray) containing control wells and substrate wells wi
- Z-1847-2011 · Feb 28, 2011 · TerminatedBD Phoenix" Panel NMIC/ID-123, Catalog # 448723, packaged 25 panels/carton, and labeled in part ***Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152 USA (800) 638-866
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page