[pending] BD BACTEC Blood Culture System, labeled as the following: 1. BACTEC 9120 System, Catalog Numbers:
Pending LLM rewrite. Source: FDA_DEVICE Z-0237-2026.
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: Pending LLM scoring against the rubric.
Plain-English summary
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.
The recalled product
- Product
- BD BACTEC Blood Culture System, labeled as the following: 1. BACTEC 9120 System, Catalog Numbers: 445570, 445702. 2. INSTRUMENT BACTEC 9120 UNREPAIRED, Catalog Number: 44557008.
- Manufacturer
- Becton Dickinson & Co.
- Category
- Medical Device — Devices
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)
- 1. Catalog Number
- (Serial Numbers): 445570
- UDI/DI: 00382904455705 (UB4523
- UB3416
- UB3975
- UB3871A
- UB3753
- UB4823
- DB2572
- UB4642
- UB3414
- UM1431
- UB3731
- UB1470
- UB5555
- UM1395
- UB4212
- UB3555
- UB4159
- UB4778
Distribution
Distributed nationwide across the United States.
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