BD Phoenix™ PMIC/ID-108 448608Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 30382904486083), received between Mar 3, 2021 and Sep 15, 2023 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (4 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.

Recalls naming this device

1. 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-0762-2021 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 15, 2023Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT WHILE USING BD PHOENIX¿ PMIC/ID-108 THAT THERE WAS A INCORRECT LABEL INFORMATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN REVIEWING DOCUMENTATION ON THE BD WEBSITE, TECHNICAL SERVICES IDENTIFIED A DISCREPANCY IN THE IFU RECORD. WHEN SEARCHING FOR THE IFU FOR CAT # 448608, THE IFU FOR NMIC-303 LOADS. NO IMPACT TO PATIENTS OR CUSTOMERS WAS ASSOCIATED WITH THIS DISCREPANCY AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17758408 ↗
• MalfunctionOct 3, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED BY THE CUSTOMER THAT THEY HAD MISIDENTIFICATIONS ON BD PHOENIX¿ PMIC/ID-108. THERE WAS ONE OCCURRENCE IN THIS EVENT WITH PATIENT INVOLVEMENT BUT PATIENT TREATMENT WAS NOT AFFECTED AND THERE WERE NO ADVERSE EVENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE CUSTOMER: CUSTOMER IS REPORTING MISIDENTIFICATION WITH PANEL 448608, LOT 2048460. PATIENT IDENTIFIER: (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15529323 ↗
• MalfunctionOct 3, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED BY THE CUSTOMER THAT THEY HAD MISIDENTIFICATIONS ON BD PHOENIX¿ PMIC/ID-108. THERE WAS ONE OCCURRENCE IN THIS EVENT WITH PATIENT INVOLVEMENT BUT PATIENT TREATMENT WAS NOT AFFECTED AND THERE WERE NO ADVERSE EVENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE CUSTOMER: "CUSTOMER IS REPORTING MISIDENTIFICATION WITH PANEL 448608, LOT 2048460. PATIENT IDENTIFIER: (B)(6)."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15529199 ↗
• MalfunctionOct 3, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED BY THE CUSTOMER THAT THEY HAD MISIDENTIFICATIONS ON BD PHOENIX¿ PMIC/ID-108. THERE WAS ONE OCCURRENCE IN THIS EVENT WITH PATIENT INVOLVEMENT BUT PATIENT TREATMENT WAS NOT AFFECTED AND THERE WERE NO ADVERSE EVENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE CUSTOMER: "CUSTOMER IS REPORTING MISIDENTIFICATION WITH PANEL 448608, LOT 2048460. PATIENT (B)(6)."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15529161 ↗
• MalfunctionMar 3, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED WHILE TESTING WITH BD PHOENIX¿ PMIC/ID-108 AN UNSPECIFIED PANEL WAS USED WITH DIFFERENT SWABS AND STAPH IDENTIFICATIONS DID MATCH. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION, THE CUSTOMER HAS NOT RESPONDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11404870 ↗