BACTEC 9120 System Recalled Due to Compromised Service Credentials
BD recalled BACTEC 9120 Systems because technical support credentials were compromised by an unauthorized actor. Until credentials are updated, there is a risk of unauthorized access to the devices and associated data.
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: Class II device with compromised technical support credentials creating risk of unauthorized access to medical device systems and data. While no actual unauthorized access or patient harm has been reported, this qualifies as a risk-of-harm product scenario per the rubric, warranting a High severity rating.
Plain-English summary
BD (Becton Dickinson & Co.) is recalling the BACTEC 9120 System (Model 445570) due to compromised technical support credentials. Approximately 1,087 units were distributed worldwide.
BD confirmed that product service credentials used by its technical support teams were accessed by an unauthorized actor. These credentials provide access to certain BACTEC 9120 Systems. Until the credentials are updated, there is a risk of unauthorized access that could impact the confidentiality, integrity, and availability of the devices and associated data.
The recall affects healthcare facilities and laboratories worldwide using BACTEC 9120 Systems. Customers should contact BD to verify their credentials have been updated and to confirm appropriate security measures are in place.
Users should work with BD to ensure all compromised credentials have been replaced and that any required security updates have been applied to their systems.
The recalled product
- Product
- BACTEC 9120 System Version or Model: 445570 Catalog Number: 445570
- Manufacturer
- Becton Dickinson & Co.
- Hazard
- credential-compromise
- unauthorized-access
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: 445570
- UDI-DI: 00382904455705
- Serial Numbers: UB4523
- UB3416
- UB3975
- UB3871A
- UB3753
- UB4823
- UB3905
- DB2572
- UB4642
- UB3414
- UM1431
- UB3731
- UB1470
- UB5555
- UM1395
- UB4212
- UB3555
- UB4159
Distribution
Distributed nationwide across the United States.
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