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BD MAX™ Cdiff (US) 443418

by Becton, Dickinson and Company

BD MAX Cdiff (US) 443418 is a clostridium difficile nucleic acid IVD (FDA Class II; FDA product code OZN, C.Difficile toxin gene amplification assay) made by Becton, Dickinson and Company, cleared under FDA 510(k) K130470 on 2 Apr 2013 and listed in FDA GUDID since 19 May 2016 (UDI-DI 00382904434182), active as of 26 Oct 2026. 2 FDA recalls are linked to it.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

2 ongoing

This device is named in the recall

Documents

510(k) K130470

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 26 Oct 2026.

Regulatory status

as of registry sync 26 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00382904434182 UDI-DI Date19 May 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK130470 Date2 Apr 2013DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K130470 decided 2 Apr 2013 Active
  • FDA GUDID UDI-DI 00382904434182 listed 19 May 2016 Listed

Recalls

2 recalls · 2 ongoing · FDA

    • Ongoing Z-0238-2026 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-0590-2025 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.

Timeline

4 dated events

  1. Cleared FDA 510(k) K130470
  2. Listed FDA GUDID 00382904434182
  3. Recall initiated FDA recalls Z-0590-2025
  4. Recall initiated FDA recalls Z-0238-2026

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
BD MAX™ Cdiff (US)
Generic name
Clostridium difficile nucleic acid IVD, kit, nucleic acid technique (NAT)
Model / Ref / Catalog
443418
Primary DI / UDI-DI
00382904434182
510(k) Number
FDA product code
OZN
GMDN term
Clostridium difficile nucleic acid IVD, kit, nucleic acid technique (NAT)
Device class
Class II
Regulation number
866.3130
GUDID distribution status
In Commercial Distribution

Related devices

Category: Clostridium difficile nucleic acid IVD, kit, nucleic acid technique (NAT)

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Properties

  • Single use
  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
Other properties (10, all answered No)