Bd Max Gbs Assay, Bd Max Instrument

• • Ongoing Z-0238-2026 FDA Class II ·initiated 23 Sep 2025 ·via K111860, on the same 510(k)

  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-1004-2025 FDA Class II ·initiated 19 Dec 2024

  Potential for signal drift in specific lots of BD PCR Cartridges.

• • Ongoing Z-0590-2025 FDA Class II ·initiated 31 Oct 2024 ·via K111860, on the same 510(k)

  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-1864-2017 FDA Class II ·initiated 29 Jul 2015 ·via K111860, on the same 510(k)

  The BD MAX System software version 4.44A contains a software anomaly that has the potential to affect some Open System Reagent (OSR) customers utilizing User Defined Protocol (UDP) assays. Customers utilizing only IVD assays are not affected. This anomaly may cause the OSR customer system to incorrectly switch the columns of the truth table on the users display. If the user tries to fix their display data, the display will appear correct however, the database may become incorrect, potentially resulting in incorrect results reporting. BD is able to trace the issue to a limited number of instruments that have software version 4.44A installed. Note that the problem only affects customers that are either creating a new UDP with Result Logic or modifying the Result Logic of an existing UDP.

• • Terminated Z-1662-2013 FDA Class III ·initiated 31 May 2013

  Electrical power module installed on some in vitro diagnostic instruments does not meet industry standards as labeled.

• • Terminated Z-0976-2013 FDA Class II ·initiated 11 Dec 2012

  Cartridges are not sealing properly during PCR testing and may cause false results, indeterminates and/or invalid runs.

• • Terminated Z-0701-2013 FDA Class II ·initiated 18 Sep 2012

  Clinical diagnostic instrument may exhibit minor defects, which could lead to erroneous test results.

Recalls marked "via" name another device cleared under the same FDA submission as this one.

510(k) Number

K111860 ↗

FDA Product Code

NJR

Device Class

Class I

Regulation

21 CFR Part 866.3740

Advisory Committee

Microbiology

FDA Decision

SESE Substantially Equivalent

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