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BD Phoenix Automated Microbiology System - Vancomycin (0.5-32 Ug/Ml)

by Becton, Dickinson & CO 510(k)

Active United States

510(k) K131331

Overview

The BD Phoenix Automated Microbiology System - Vancomycin (0.5-32 Ug/Ml) is an automated system for antimicrobial susceptibility testing. It is designed for the quantitative determination of antimicrobial susceptibility by minimal inhibitory concentration (MIC) of most gram positive bacteria isolates from pure culture belonging to the genera Staphylococcus and Enterococcus.

The system is supplied as a reusable instrument and is intended for use in clinical microbiology laboratories. It has received FDA 510(k) clearance under product code LON and regulation number 866.1645, with a traditional clearance type and decision date of 2013-07-10.

AI-generated from registry data, 25 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

Recall ongoing. 4 ongoing FDA recalls. See recalls

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK131331 Date10 Jul 2013ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

4 recalls · 4 ongoing · FDA

    • Ongoing Z-0239-2026 FDA Class II initiated 23 Sep 2025

    Product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product service credentials are updated, there is a risk of unauthorized access that may impact the confidentiality, integrity and/or availability of the relevant products and associated data.

    • Ongoing Z-0592-2025 FDA Class II initiated 31 Oct 2024

    BD confirmed that product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product service credentials are updated, there is a risk of unauthorized access that may impact the confidentiality, integrity and/or availability of the relevant products and associated data.

  • 2 recalls, same reason

    • Ongoing Z-3246-2024 FDA Class II initiated 1 Aug 2024
    • Ongoing Z-3247-2024 FDA Class II initiated 1 Aug 2024

    Escherichia coli (E. coli) misidentification for clinical samples that were tested on BD Phoenix" M50 instrument and BD Phoenix" 100, may lead to misdiagnosis and inappropriate treatment of infections caused by E. coli,

Specification

510(k)

510(k) Number
FDA Product Code
LON
Device Class
Class II
Regulation
21 CFR Part 866.1645
Advisory Committee
Microbiology
FDA Decision
SESE Substantially Equivalent

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Questions

  • What is the BD Phoenix Automated Microbiology System - Vancomycin (0.5-32 Ug/Ml) used for?

    It is used for the quantitative determination of antimicrobial susceptibility by minimal inhibitory concentration (MIC) of most gram-positive bacteria isolates from pure culture, specifically targeting genera Staphylococcus and Enterococcus, enabling automated susceptibility testing in clinical microbiology laboratories.

  • How is the BD Phoenix Automated Microbiology System - Vancomycin (0.5-32 Ug/Ml) supplied and intended for use?

    The system is supplied as a reusable instrument and is intended for use in clinical microbiology laboratories to perform automated antimicrobial susceptibility testing, supporting routine identification and susceptibility profiling of bacterial isolates.

  • What regulatory clearance does the BD Phoenix Automated Microbiology System - Vancomycin (0.5-32 Ug/Ml) have?

    It has received FDA 510(k) clearance under product code LON and regulation number 866.1645, with a traditional clearance type and decision date of July 10, 2013, confirming its substantial equivalence to a legally marketed predicate device.