BD Phoenix™ Automated Microbiology System 448100Recalls & reported problems

Summary

The FDA's MAUDE database contains 40 adverse event reports that list this exact device (DI 00382904481001), received between Jan 22, 2021 and Feb 23, 2026 — classified as 40 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (38 reports).

1 FDA recall record name this device's identifier, 1 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. 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-3247-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 40 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 23, 2026Incorrect Measurement

  IT WAS REPORTED WHILE USING THE BD PHOENIX¿ AUTOMATED MICROBIOLOGY SYSTEM AN UNSPECIFIED NUMBER OF PATIENT ISOLATES HAD IMPROPER RESULTS. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24416041 ↗
• MalfunctionSep 4, 2025Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED WHILE USING THE BD PHOENIX¿ AUTOMATED MICROBIOLOGY SYSTEM A PATIENT ISOLATE HAD ABNORMAL ANTIMICROBIAL SUSCEPTIBILITY RESULTS. NO FURTHER INFORMATION WAS PROVIDED. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22964613 ↗
• MalfunctionJul 17, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE USING THE BD PHOENIX¿ AUTOMATED MICROBIOLOGY SYSTEM, A PATIENT RESULT WAS FALSE RESISTANT FOR VANCOMYCIN. THERE WAS NO REPORT OF PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22531094 ↗
• MalfunctionOct 7, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED WHILE USING THE BD PHOENIX¿ AUTOMATED MICROBIOLOGY SYSTEM AN UNSPECIFIED NUMBER OF PATIENTS HAD VARIATIONS IN MIC RESULTS FOR BOTH GRAM NEGATIVE AND GRAM-POSITIVE ISOLATES. THE USER NOTED THAT ALL OF THE ISOLATES WERE CONFIRMED WITH A MANUAL ANTIBIOGRAM. THE USER WAS ALSO ADVISED TO CHECK FOR POSSIBLE CONTAMINATION. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20389562 ↗
• MalfunctionMay 22, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED WHILE USING THE BD PHOENIX¿ AUTOMATED MICROBIOLOGY SYSTEM AN UNSPECIFIED NUMBER OF PATIENT MIC RESULTS WERE INCONSISTENT WITH WHAT THE USER EXPECTED. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19374458 ↗
• MalfunctionMay 21, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED WHILE USING THE BD PHOENIX¿ AUTOMATED MICROBIOLOGY SYSTEM FREQUENT MISIDENTIFICATIONS OCCURRED WITH PATIENT SAMPLES. THE USER NOTED TWO SPECIFIC MISIDENTIFICATIONS, ONE ISOLATE WAS IDENTIFIED AS AN E. COLI, AND THE OTHER WAS IDENTIFIED AS MORGANELLA MORGANII. THE USER USED MALDI TO CORRECTLY IDENTIFY THE ISOLATES. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19363497 ↗
• MalfunctionMar 8, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED WHILE USING THE BD PHOENIX¿ AUTOMATED MICROBIOLOGY SYSTEM THE USER RECEIVED FALSE RESULTS. THE EXPECTED RESULT WAS E. COLI, BUT THE PATIENT ISOLATES WERE EITHER IDENTIFIED AS CITROBACTER FARMERI OR ENTEROBACTER CLOACAE. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18865354 ↗
• MalfunctionFeb 21, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING USE WITH THE BD PHOENIX¿ AUTOMATED MICROBIOLOGY SYSTEM, THE INSTRUMENT FAILED TO CORRECTLY IDENTIFY ORGANISMS. THERE WAS NO REPORT OF PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18746799 ↗
• MalfunctionJan 31, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED DURING USE OF THE BD PHOENIX¿ AUTOMATED MICROBIOLOGY SYSTEM THERE WAS FALSE RESISTANCE IN PATIENT RESULTS. THE RESULTS WERE VERIFIED BY MANUAL METHODOLOGY. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18614551 ↗
• MalfunctionJan 9, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING USE OF THE BD PHOENIX¿ AUTOMATED MICROBIOLOGY SYSTEM, THERE WAS A SAMPLE MISIDENTIFICATION. NO PATIENT IMPACT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18478025 ↗
• MalfunctionDec 26, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED WHILE TESTING WITH THE BD PHOENIX¿ AUTOMATED MICROBIOLOGY SYSTEM DISCREPANT RESULTS WERE OBTAINED FOR SENSITIVITY TESTS FOR CARBAPENEMS, VANCOMYCIN AND TEICOPLANIN. NO PATIENT IMPACT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18393619 ↗
• MalfunctionDec 22, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING USE WITH THE BD PHOENIX¿ AUTOMATED MICROBIOLOGY SYSTEM, THERE WERE ISSUES WITH IDENTIFICATION OF PATIENT SAMPLE. THERE WAS NO REPORT OF PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18383741 ↗
• MalfunctionJul 28, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE USING THE BD PHOENIX¿ AUTOMATED MICROBIOLOGY SYSTEM THAT THERE WAS MISIDENTIFICATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (B)(6). THE CASE PROCESS WAS REVIEWED UNTIL THE CORRECT IDENTIFICATION IS CONFIRMED WITH A NEW ASSEMBLY IN THE PHOENIX EQUIPMENT OR THE MANUAL TEST (COAGULASA) DOES NOT RELEASE THE RESULT. THE ENGINEERING TEAM WAS REQUESTED TO CLEAN OPTICAL EQUIPMENT DUE TO SOOT ENTERING THE LABORATORY NEAR THE MAIN AVENUE WHERE THERE IS A LOT OF TRAFFIC. EPIDERMIS WAS IDENTIFIED IN A PANEL AND AN AUREUS WAS SEEN IN THE CULTURE MEDIUM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17411206 ↗
• MalfunctionJul 5, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE USING BD PHOENIX¿ AUTOMATED MICROBIOLOGY SYSTEM, THERE WAS FALSE RESISTANCE OF ONE PANEL. THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "S. AUREUS TEICOPLANIN RESISTANT ON PHOENIX (MIC=4). ON FURTHER TESTING USING E-TEST THE MIC WAS 1MG/L. PHOENIX ALSO CALLED AMC=R ON A PROTEUS MIRABILIS, WHICH WAS FULLY SENSITIVE ON DISC. WHICH PANELS WERE USED? PMIC LOT: 2285329, NMIC LOT 2263172. WHAT ARE THE LOT NUMBERS FOR THE KITS USED? AST INDICATOR: LOT 2298623 EXP 21/10/23, ID BROTH LOT 2280803 EXP 03/10/23, AST BROTH LOT 2216995 26/07/23".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17255219 ↗
• MalfunctionMay 25, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT BD PHOENIX¿ AUTOMATED MICROBIOLOGY SYSTEM HAS HAD SEVERAL MIS-ID¿S. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTED THAT THEY HAVE HAD SEVERAL MIS-ID¿S. THEY PERFORM BIOFIRE ON BLOOD CULTURES, AND THE PHOENIX ID¿S WERE DIFFERENT THAN MALDI. ONE ISOLATE WAS IDENTIFIED BY MALDI AS E. COLI AND PHOENIX CALLED IT K. PNEUMONIAE. ANOTHER WAS CALLED PROTEUS BY MALDI BUT PROVIDENCIA BY PHOENIX. CUSTOMER DID NOT HAVE FULL DETAILS BUT WILL SEND IN LAB REPORTS. CUSTOMER WAS ALSO UNAWARE TO THE INCIDENT START DATE, BUT SAID IT WAS LAST WEEK OR THE WEEK BEFORE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17002744 ↗
• MalfunctionMay 22, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT BD PHOENIX¿ AUTOMATED MICROBIOLOGY SYSTEM IDENTIFICATION IS NOT PASSING AND IT ONLY HAPPENS WITH BASILS AND COCCI. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT DOES NOT PASS IDENTIFICATION, IT ONLY INDICATES SENSITIVITY AND IT ONLY HAPPENS WITH BASILS AND COCCI.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16981468 ↗
• MalfunctionMay 8, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE USING THE BD PHOENIX¿ AUTOMATED MICROBIOLOGY SYSTEM THAT THERE WAS A NORMALIZER ALERT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER PROBLEM: NORMALIZER REPLACED UNIT NOW GIVING E23 NORMALIZER PANEL ERROR. NORMALIZER REPLACED UNIT NOW GIVING E23 NORMALIZER PANEL ERROR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16887580 ↗
• MalfunctionMay 5, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE USING THE BD PHOENIX¿ AUTOMATED MICROBIOLOGY SYSTEM THAT THERE WAS FALSE RESISTANCE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CLIENT FREQUENTLY REPORTS CARBAPENEM RESISTANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16876786 ↗
• MalfunctionApr 26, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE USING THE BD PHOENIX¿ AUTOMATED MICROBIOLOGY SYSTEM THAT THERE WAS FALSE RESISTANCE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER ONLY SET UP A FEW SAMPLES. 2 STAPHS WERE VANCOMYCIN RESISTANT, BUT WHEN REPEATED ON THE OTHER INSTRUMENT THEY WERE SENSITIVE. LOG FILE ANALYSIS SHOWS: SOURCE MONITOR HIGH WARNING: FOR TIER<A> FRONT UV ACTIVE AT 33% INTENSITY SLIGHTLY HIGH. NOTICES FOR HIGH WELL NORMALIZER READINGS IN TIER C, LOW IN TIER B, D. I CALLED THE CUSTOMER BACK AND SELECTED FORCED REAR UV BULB INTO SERVICE AND FORCED RGB/LED ADJUSTMENTS WHICH ARE PENDING. STEPS TAKEN WITH CUSTOMER/TROUBLESHOOTING: CUSTOMER HAS HAD SEVERAL PANELS THAT HAD LEVOFLOXACIN OR CIPRO FAILURES WHEN THE PANELS ARE RUN IN THIS INSTRUMENT. CUSTOMER REPEATED THEM IN THEIR OTHER INSTRUMENT AND EVERYTHING WORKED FINE. LOG FILE SAVED TO Q:\PHOENIX 100 ACCOUNTS\ST FRANCIS HEALTH SYSTEM\1985069 IS THE SOFTWARE VERSION AVAILABLE ON THE ¿PRODUCT ATTRIBUTES¿ PAGE (Y/N)?: Y.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16820164 ↗
• MalfunctionMar 14, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT BD PHOENIX¿ AUTOMATED MICROBIOLOGY SYSTEM INSTRUMENT HAS IDENTIFICATION FAILURES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER INFORMS THAT EQUIPMENT HAS IDENTIFICATION AND ANTIBIOGRAM FAILURES ABORTING PANELS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16537422 ↗
• MalfunctionMar 9, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT BD PHOENIX¿ AUTOMATED MICROBIOLOGY SYSTEM NMIC/ID-307 PANEL KEEPS GETTING MISIDENTIFIED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THEY ARE ONLY GETTING MISIDENTIFICATIONS ON THE NMIC/ID-307 PANEL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16513619 ↗
• MalfunctionDec 20, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING USE WITH THE BD PHOENIX¿ AUTOMATED MICROBIOLOGY SYSTEM, ERRONEOUS RESULTS WERE OBTAINED. THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTS THAT QC IS BEING MARKED AS "REVIEW" BUT MEROPENEM/VAPORBACTAM, CPO SCREEN AND CPO CLASSIFICATION SHOW AS "PASS" PHOENIX 100 LOGS SHOW PANELS FAILED CPO CLASSIFICATION BUT EPICENTER AND PHOENIX SOFTWARE INTERFACE ARE SHOWING AS PASS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16018701 ↗
• MalfunctionDec 20, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  REPORT 2 OF 3; IT WAS REPORTED THAT DURING USE WITH THE BD EPICENTER¿ SINGLE USER SOFTWARE, ERRONEOUS RESULTS WERE OBTAINED. THERE WAS NO REPORT OF PATIENT IMPACT; THIS WAS A QC REPORTING ISSUE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTS THAT QC IS BEING MARKED AS "REVIEW" BUT MEROPENEM/VAPORBACTAM, CPO SCREEN AND CPO CLASSIFICATION SHOW AS "PASS" PHOENIX 100 LOGS SHOW PANELS FAILED CPO CLASSIFICATION BUT EPICENTER AND PHOENIX SOFTWARE INTERFACE ARE SHOWING AS PASS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16018311 ↗
• MalfunctionDec 15, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING USE WITH THE BD EPICENTER¿ SINGLE USER SOFTWARE, ERRONEOUS RESULTS WERE OBTAINED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTS THAT QC IS BEING MARKED AS "REVIEW" BUT MEROPENEM/VAPORBACTAM, CPO SCREEN AND CPO CLASSIFICATION SHOW AS "PASS" PHOENIX 100 LOGS SHOW PANELS FAILED CPO CLASSIFICATION BUT EPICENTER AND PHOENIX SOFTWARE INTERFACE ARE SHOWING AS PASS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15992902 ↗
• MalfunctionOct 17, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE USING THE BD PHOENIX¿ AUTOMATED MICROBIOLOGY SYSTEM THERE WAS AN ERROR ID RESULT SHOWING. NO PATIENT IMPACT WAS REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ERROR ID RESULT SHOWING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15613207 ↗