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NMIC-312 449082Recalls & reported problems

Becton, Dickinson And Company · NMIC-312 · Class 2

Adverse event reports
64
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 64 adverse event reports that list this exact device (DI 30382904490820), received between Jan 16, 2026 and Sep 30, 2026 — classified as 64 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (64 reports).

2 other recalls cover devices cleared under the same FDA submission (K020322, K023444, K023634, K023858, K033458, K042932, K060214, K060257, K060444, K060447, K061327, K061355, K062207, K062944, K062945, K063486, K063573, K063811, K063824, K123404, K132674, K132909, K163637, K173252, K173523, K181665, K233986); 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.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 2 reportsFeb 2026: 0 reportsMar 2026: 9 reportsApr 2026: 1 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 52 reportsOct 2026: 0 reports20242025202652
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Incorrect, Inadequate or Imprecise Result or Readings64
  • False Negative Result1

Patient problems

  • No Clinical Signs, Symptoms or Conditions64

Recent adverse event reports

The 25 most recent of 64 reports, in the reporter's own words as published by the FDA.

  • MalfunctionSep 30, 2026Incorrect, Inadequate or Imprecise Result or Readings

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50953972 ↗
  • MalfunctionSep 30, 2026Incorrect, Inadequate or Imprecise Result or Readings

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50950611 ↗
  • MalfunctionSep 30, 2026Incorrect, Inadequate or Imprecise Result or Readings

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50950610 ↗
  • MalfunctionSep 30, 2026Incorrect, Inadequate or Imprecise Result or Readings

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50950609 ↗
  • MalfunctionSep 30, 2026Incorrect, Inadequate or Imprecise Result or Readings

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50950607 ↗
  • MalfunctionSep 30, 2026Incorrect, Inadequate or Imprecise Result or Readings

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50950606 ↗
  • MalfunctionSep 30, 2026Incorrect, Inadequate or Imprecise Result or Readings

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50950605 ↗
  • MalfunctionSep 30, 2026Incorrect, Inadequate or Imprecise Result or Readings

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50950604 ↗
  • MalfunctionSep 30, 2026Incorrect, Inadequate or Imprecise Result or Readings

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50950598 ↗
  • MalfunctionSep 30, 2026Incorrect, Inadequate or Imprecise Result or Readings

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50950597 ↗
  • MalfunctionSep 30, 2026Incorrect, Inadequate or Imprecise Result or Readings

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50950596 ↗
  • MalfunctionSep 30, 2026Incorrect, Inadequate or Imprecise Result or Readings

    It was reported while using the BD Phoenix¿ NMIC-312 a patient isolate had a high MIC (false resistant) for the drug Imipenem. No health impact or consequence reported.This is report 8 of 13.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50950595 ↗
  • MalfunctionSep 30, 2026Incorrect, Inadequate or Imprecise Result or Readings

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50950594 ↗
  • MalfunctionSep 30, 2026Incorrect, Inadequate or Imprecise Result or Readings

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50948316 ↗
  • MalfunctionSep 30, 2026Incorrect, Inadequate or Imprecise Result or Readings

    It was reported while using the Panel Phoenix NMIC-312 a patient isolate had a high MIC result for the drug Imipenem. The health impact or consequence was unknown by the user.This is report 9 of 10.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50948315 ↗
  • MalfunctionSep 30, 2026Incorrect, Inadequate or Imprecise Result or Readings

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50948314 ↗
  • MalfunctionSep 30, 2026Incorrect, Inadequate or Imprecise Result or Readings

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50948313 ↗
  • MalfunctionSep 30, 2026Incorrect, Inadequate or Imprecise Result or Readings

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50948312 ↗
  • MalfunctionSep 30, 2026Incorrect, Inadequate or Imprecise Result or Readings

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50948311 ↗
  • MalfunctionSep 30, 2026Incorrect, Inadequate or Imprecise Result or Readings

    It was reported while using the Panel Phoenix NMIC-312 a patient isolate had a high MIC result for the drug Imipenem. The health impact or consequence was unknown by the user.This is report 5 of 10.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50948310 ↗
  • MalfunctionSep 30, 2026Incorrect, Inadequate or Imprecise Result or Readings

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50948309 ↗
  • MalfunctionSep 30, 2026Incorrect, Inadequate or Imprecise Result or Readings

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50948306 ↗
  • MalfunctionSep 30, 2026Incorrect, Inadequate or Imprecise Result or Readings

    It was reported while using the BD Phoenix¿ NMIC-312 a patient isolate had a high MIC (false resistant) for the drug Imipenem. No health impact or consequence reported.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50947216 ↗
  • MalfunctionSep 30, 2026Incorrect, Inadequate or Imprecise Result or Readings

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50945871 ↗
  • MalfunctionSep 29, 2026Incorrect, Inadequate or Imprecise Result or Readings

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50941247 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K020322, K023444, K023634, K023858, K033458, K042932, K060214, K060257, K060444, K060447, K061327, K061355, K062207, K062944, K062945, K063486, K063573, K063811, K063824, K123404, K132674, K132909, K163637, K173252, K173523, K181665, K233986. One submission often covers many models, so check the product and lot details in each record.

  • Z-1398-2024 · Feb 29, 2024 · Open, Classified
    BD Phoenix NMIC-306 Panel is a self-inoculating (when used with a BD Phoenix Automated Microbiology System) polystyrene panel (tray) containing control wells and substrate wells wi
  • Z-1847-2011 · Feb 28, 2011 · Terminated
    BD Phoenix" Panel NMIC/ID-123, Catalog # 448723, packaged 25 panels/carton, and labeled in part ***Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152 USA (800) 638-866

Other SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION devices

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.