BD Phoenix M50 Automated Microbiology System Service Credentials Exposed
BD confirmed that service credentials used by technical support teams were accessed by an unauthorized actor, creating a risk of unauthorized access to BD microbiology systems and associated data.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: This FDA Class II medical device recall involves a risk-of-harm scenario where compromised service credentials on a diagnostic system could potentially impact data integrity and system availability. No actual unauthorized access events, patient harm, or system malfunctions have been reported.
Plain-English summary
The BD Phoenix M50 Automated Microbiology System (Model 443624) is the subject of this recall. Product service credentials used by some BD technical support teams to access this system 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 system and associated data. Approximately 4,411 units of the affected system have been distributed worldwide, comprising 567 units in the United States and 3,844 units internationally.
The recalled product
- Product
- BD Phoenix M50 Automated Microbiology System Version or Model: 443624 Catalog Number: 443624
- 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: 443624
- UDI-DI:00382904436247
- Serial Numbers: PF4176
- PF4182
- PF2302
- PF4198
- PF4149
- PF4189
- PF4202
- PF2699
- PF4200
- PF4207
- PF4209
- PF2704
- PF2640
- PF2769
- PF3383
- PF2742
- PF5292
- PF4215
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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