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Bd Max™ Mrsa 442953

by Geneohm Sciences Canada Inc

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

2 ongoing

Recall on shared 510(k) K120138; other models may be affected

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00382904429539 UDI-DIDate27 Jul 2016ListedStatusListed GUDID: not in commercial distribution

Recalls

4 recalls · 2 ongoing · FDA

    • Ongoing Z-0238-2026 FDA Class II initiated 23 Sep 2025 on shared 510(k) K120138

    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 on shared 510(k) K120138

    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.

    • Terminated Z-2328-2019 FDA Class II initiated 17 Jul 2019

    The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly.

    • Terminated Z-2618-2014 FDA Class II initiated 23 Jul 2014

    The performance of the assay no longer conforms to this statement in the Analytical Specificity section of the Package Insert: One hundred-eleven (111) out of 111 MSSA strains tested at extremely high concentrations (> 106 CFU/swab), produced negative results with the BD MAX MRSA Assay. One of the samples tested with each of the CAP surveys MRS5-A 2014 and MRS5-B 2014 yielded false positive results.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Bd Max™ Mrsa
Generic Name
MRSA nucleic acid IVD, kit, nucleic acid technique (NAT)
Model / Ref / Catalog
442953
Primary DI / UDI-DI
00382904429539
510(k) Number
FDA Product Code
NQX
GMDN Term
MRSA nucleic acid IVD, kit, nucleic acid technique (NAT)
Device Class
Class II
Regulation Number
866.1640
GUDID distribution status
Not in Commercial Distribution

Other devices from Geneohm Sciences Canada Inc

Properties

  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (10)

  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No