BD Phoenix™ SMIC-101 448803Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 30382904488032), received between May 20, 2022 and Feb 13, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (5 reports).

3 other recalls cover devices cleared under the same FDA submission (K032675, K050745, K050747, K050780, K050865, K050881, K050946, K050982, K051109, K051138, K051204, K051266, K051272, K051692, K062206); 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. How this data works · Data updated Oct 13, 2026.

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.

• MalfunctionFeb 13, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED WHILE USING THE BD PHOENIX¿ SMIC-101 THE MIC RESULT FOR THE DRUG VANCOMYCIN IS SUPPRESSED AND CLINDAMYCIN IS BEING REPORTED INSTEAD. IT IS TO BE NOTED THE RULE FOR SUPPRESSION IS ACCURATE. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24337386 ↗
• MalfunctionJul 28, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED WHILE USING THE BD PHOENIX¿ SMIC-101 PATIENT ISOLATE RESULTS FOR THE DRUGS ERYTHROMYCIN AND CLINDAMYCIN DO NOT MATCH THE D TEST RESULT NOR REPEAT RESULTS ON THE DEVICE. PATIENT ONE HAD A SENSITIVE CLINDAMYCIN AND A RESISTANT ERYTHROMYCIN RESULT. THE D TEST RESULT SHOWS BOTH CLINDAMYCIN AND ERYTHROMYCIN AS RESISTANT. NO HEALTH IMPACT OR CONSEQUENCE REPORTED. REPORT 1 OF 3.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22636456 ↗
• MalfunctionJul 28, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED WHILE USING THE BD PHOENIX¿ SMIC-101 PATIENT ISOLATE RESULTS FOR THE DRUGS ERYTHROMYCIN AND CLINDAMYCIN DO NOT MATCH THE D TEST RESULT NOR REPEAT RESULTS ON THE DEVICE. PATIENT THREE HAD A SENSITIVE CLINDAMYCIN AND A RESISTANT ERYTHROMYCIN RESULT. THE D TEST RESULT SHOWS BOTH CLINDAMYCIN AND ERYTHROMYCIN AS RESISTANT. NO HEALTH IMPACT OR CONSEQUENCE REPORTED. REPORT 3 OF 3.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22636282 ↗
• MalfunctionJul 28, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED WHILE USING THE BD PHOENIX¿ SMIC-101 PATIENT ISOLATE RESULTS FOR THE DRUGS ERYTHROMYCIN AND CLINDAMYCIN DO NOT MATCH THE D TEST RESULT NOR REPEAT RESULTS ON THE DEVICE. PATIENT TWO HAD A RESISTANT CLINDAMYCIN AND A SENSITIVE ERYTHROMYCIN RESULT. THE D TEST RESULT SHOWS BOTH CLINDAMYCIN AND ERYTHROMYCIN AS RESISTANT. NO HEALTH IMPACT OR CONSEQUENCE REPORTED. REPORT 2 OF 3.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22636121 ↗
• MalfunctionMay 20, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT BD PHOENIX¿ SMIC-101 HAS INSUFFICIENT INDICATOR AND NO GROWTH WITH 448803 PANELS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER IS REPORTING INSUFFICIENT INDICATOR AND NO GROWTH WITH 448803 PANELS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14455823 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K032675, K050745, K050747, K050780, K050865, K050881, K050946, K050982, K051109, K051138, K051204, K051266, K051272, K051692, K062206. One submission often covers many models, so check the product and lot details in each record.

• Z-0935-2019 · Dec 20, 2018 · Terminated
  Phoenix AP AST Indicator Bag, Catalog Number 246006
• Z-0933-2019 · Dec 20, 2018 · Terminated
  Phoenix AST-s Indicator, Catalog Number 246009
• Z-0934-2019 · Dec 20, 2018 · Terminated
  Phoenix AST Indicator, Catalog Number 246004