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Bd Max Cdiff Assay, Bd Max Instrument

by Geneohm Sciences Canada, Inc. (Bd Diagnostics)

510(k) K130470

Active United States

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

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK130470 Date2 Apr 2013ClearedStatusActive

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.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
OZN
Device Class
Class II
Regulation
21 CFR Part 866.3130
Advisory Committee
Microbiology
FDA Decision
SESE Substantially Equivalent

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