BD Phoenix™ PMIC-108 448418Recalls & reported problems
Becton, Dickinson And Company · BD Phoenix™ PMIC-108 · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 30382904484188), received between Feb 5, 2020 and Jul 25, 2024 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (2 reports).
1 FDA recall record name this device's identifier.
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
Recalls naming this device
- Dec 8, 2020Terminated
BD Phoenix Sulfamethoxazole-trimethoprim (SXT) Resistance, false resistant SXT result with S. aureus could lead to a potential loss of access to a preferred antibiotic regimen and potential reduction in effectiveness of treatment of the infection
Z-0763-2021 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗
Most reported problems
Device problems
- Incorrect, Inadequate or Imprecise Result or Readings2
- Insufficient Device Problem Information1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 25, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED WHILE USING THE BD PHOENIX¿ PMIC-108 AN UNSPECIFIED NUMBER OF PATIENT SAMPLES HAVE A HIGH MIC FOR THE DRUG VANCOMYCIN FOR THE ISOLATE STAPHYLOCOCCUS AUREUS. ONE ERRONEOUS PATIENT RESULT WAS REPORTED. THERE WAS NO PATIENT TREATMENT CHANGE AS A RESULT. CONFIRMATORY TESTING PERFORMED ON THE MICROSCAN, WHERE THE ISOLATE WAS NOT RESISTANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19826703 ↗MalfunctionJul 19, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED WHILE USING THE BD PHOENIX¿ PMIC-108 AN UNSPECIFIED NUMBER OF PATIENT SAMPLES HAVE A HIGH MIC FOR THE DRUG VANCOMYCIN FOR THE ISOLATE STAPHYLOCOCCUS AUREUS. ONE ERRONEOUS PATIENT RESULT WAS REPORTED. THERE WAS NO PATIENT TREATMENT CHANGE AS A RESULT. CONFIRMATORY TESTING PERFORMED ON THE MICROSCAN, WHERE THE ISOLATE WAS NOT RESISTANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19781295 ↗InjuryFeb 5, 2020Insufficient Device Problem Information
CUSTOMER STARTED TESTING SXT AFTER SEEING AN ARTICLE ABOUT FALSE RESISTANCE IN AUTOMATED SYSTEMS. ISOLATES HAVE BEEN SENSITIVE BY (B)(6). ISOLATES ARE 18-24 HOURS OLD AND TAKEN FROM TSA W/ SB USING A COTTON SWAB. IT IS NOT KNOWN FOR SURE IF RESULTS WERE ERRONEOUS. AROUND 150 ISOLATES IN QUESTION, OVER 3 LOT NUMBERS.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9674013 ↗
Other SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION devices
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- 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
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- 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 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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