BD BACTEC FX40 Product Service Credentials Accessed by Unauthorized Actor
Unauthorized actor accessed BD technical support credentials for the BACTEC FX40 laboratory instrument. Until credentials are updated, there is a risk of unauthorized access to the system and associated data.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II voluntary precautionary recall due to exposed service credentials. No illnesses, injuries, or confirmed actual unauthorized access to systems or patient data have been reported. The source states only that there is a risk of unauthorized access, without confirming actual compromise.
Plain-English summary
The BD BACTEC FX40 Instrument (Model 442296, Catalog Number 442296) is a diagnostic laboratory device used in clinical settings. 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 availability of the relevant products and associated data.
Approximately 8,085 units are affected worldwide, including 838 in the United States and 7,247 units internationally across numerous countries. This precautionary recall has been issued to prevent potential unauthorized access while BD updates service credentials.
Healthcare facilities using affected BACTEC FX40 instruments should coordinate with BD regarding credential updates and security remediation measures.
The recalled product
- Product
- BD BACTEC FX40 Instrument Version or Model: 442296 Catalog Number: 442296
- Manufacturer
- Becton Dickinson & Co.
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Catalog No: 442296
- UDI-DI: 00382904422967
- Serial Numbers: FF7385
- FF7425
- FF2727
- FF1261
- FF2717
- FF1262
- FF7254
- FF7365
- FF7419
- FF7374
- FF6762
- FF2759
- FF2756
- FF7380
- FF9548
- FF9544
- FF7367
- FF2745
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 13 recalled by Becton Dickinson & Co. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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