BD BACTEC FX Instrument Top credential compromise enables unauthorized access risk
BD service credentials for BACTEC FX instruments were accessed by an unauthorized actor, creating risk of unauthorized system access until credentials are updated.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall following confirmed unauthorized access to medical device service credentials. Although no actual unauthorized system access or data compromise has been reported, the risk of unauthorized access to a medical device system poses potential integrity and availability concerns if credentials are not immediately updated.
Plain-English summary
BD BACTEC FX Instrument Top (Model 441385, Catalog Number 441385) has been recalled by Becton Dickinson & Co.
Product service credentials used by BD technical support teams to access certain BD BACTEC FX instruments were accessed by an unauthorized actor. Until these credentials are updated, there is a risk of unauthorized access that may impact the confidentiality, integrity, and availability of the affected products and associated data.
The recall affects 10,129 total units worldwide: 2,836 in the United States and 7,293 outside the United States. The affected instrument can be identified by Model 441385 and the full list of affected serial numbers is available through the FDA.
Customers with affected units should contact Becton Dickinson immediately to update their product service credentials and prevent potential unauthorized access to their systems.
The recalled product
- Product
- BD BACTEC FX, Instrument Top, Packaged Version or Model: 441385 Catalog Number: 441385
- 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: 441385
- UDI-DI: 00382904413859
- Serial Numbers: FT9750
- FT8660
- FT9839
- FT5241
- FT9840
- FT9841
- T10574
- FT5251
- FT9796
- FT1325
- FT9880
- FT9881
- T10575
- FT9884
- FT7169
- FT7177
- T10563
- T10519
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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