BD Phoenix™ PMIC/ID-109 448609Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 30382904486090), received between Feb 9, 2023 and Nov 27, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (3 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 18, 2026.

Recalls naming this device

1. Dec 8, 2020Class IITerminated

   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-0764-2021 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 27, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED WHILE USING THE BD PHOENIX¿ PMIC/ID-109 A PATIENT ISOLATE S. AUREUS WAS MISIDENTIFIED AS S. EPIDERMIDIS, THE USER NOTED THAT A CORRECTED REPORTED WAS MADE TO THE PROVIDER. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20792024 ↗
• MalfunctionMay 10, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE USING THE BD PHOENIX¿ PMIC/ID-109 THAT THERE WAS A PERFORMANCE ISSUE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WAS THIS ISSUE INVOLVING PATIENT OR NONPATIENT SAMPLES? PATIENT. WAS THERE ANY PATIENT IMPACT? (Y/N) N, THE TEST WAS REPEATED TO GIVE THE CORRECT RESULT TO PATIENTS. PHOENIX 448609 E. AVIUM NOT GROWING ON PANEL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16908378 ↗
• MalfunctionFeb 9, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE USING THE BD PHOENIX¿ PMIC/ID-109 THAT THERE WAS DISCREPANT RESULTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTS DISCREPANT RESULTS ON ANTIBIOTIC RESISTANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16330838 ↗