Bd Max Mrsa Assay, Bd Max Instrument

510(k) K120138

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

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

Documents

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 11 Oct 2026. What this means

Regulatory status

as of registry sync 11 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK120138	Date5 Jul 2012Cleared	StatusActive

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.

1 jurisdiction

United States — FDA 510(k) Active

510(k)