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Bactec

by Becton, Dickinson and Company United States EUDAMEDGUDID

Ref 441370

Product code MDBEMDN W02030201

Regulatory status

as of 24 Oct 2026

Recall ongoing. 4 ongoing FDA recalls. See recalls

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number038290FOSBAJMA72 Basic UDI-DIDate24 Mar 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00382904413705 UDI-DIDate22 Aug 2024ListedStatusIn distribution

Coverage

2 jurisdictions

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 AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Listed
  • Not covered
  • European Union CE/IVDR Active
  • United States GUDID listing Listed

Certificates: none listed in EUDAMED

Recalls

6 recalls · 4 ongoing · FDA

    • Ongoing Z-0236-2026 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.

  • 3 recalls, same reason

    • Ongoing Z-0596-2025 FDA Class II initiated 31 Oct 2024
    • Ongoing Z-0593-2025 FDA Class II initiated 31 Oct 2024
    • Ongoing Z-0594-2025 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

    • Terminated Z-0870-2014 FDA Class II initiated 9 Dec 2013
    • Terminated Z-0869-2014 FDA Class II initiated 9 Dec 2013

    Improperly functioning component of a diagnostic medical device may cause false negative results in clinical specimens.

Specification

EUDAMED · GUDID · synced 22 Oct 2026

Trade Name
Bactec EUDAMED
BD BACTEC™ Digital Thermometer GUDID
Generic Name
Blood culture analyser IVD
Model / Ref / Catalog
441370
Primary DI / UDI-DI
00382904413705
Basic UDI-DI
038290FOSBAJMA72
510(k) Number
FDA Product Code
MDB
EMDN Code
W02030201 Automated blood culture analysers
GMDN Term
Blood culture analyser IVD
Device Class
Class A EUDAMED
Class I GUDID
Regulation Number
866.2560
Market of Registration
Belgium
Commercial Distribution
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class A
GUDID
Class I

Manufacturer details

EUDAMED SRN
US-MF-000018910
Authorised representative
Becton Dickinson Ireland Limited IE-AR-000007610

Other devices from Becton, Dickinson and Company

See all devices from Becton, Dickinson and Company →

Properties & raw data

Show properties, registry sources and raw records
  • Professional Testing
  • Surgical Instrument
  • Prescription Use
  • Lot / Batch Number
  • Manufacturing Date
Other properties (19)
  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • New Device: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No

Sources (2)

  • EUDAMED fc5490c6-f53f-4a18-bcb7-641cea5567fd 61 fields · synced 22 Oct 2026
  • FDA UDI 3853d9fd-7815-4c37-b80c-9db3da971382 37 fields · synced 30 May 2026