BD recalled 4,283 Phoenix M50 Automated Microbiology Systems worldwide after unauthorized access to product service credentials. The unauthorized actor could access affected products and data. Labs should stop using these devices and follow the recall instructions from BD; contact BD for remediation guidance.
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.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Becton Dickinson & Co. or your healthcare provider for instructions. Notification method: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
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The BD Phoenix M50 Automated Microbiology System is used in clinical laboratories to identify and test pathogens. It is part of automated workflows in microbiology labs and supports patient diagnostic processes.
BD notes an unauthorized actor accessed product service credentials. This could lead to unauthorized access to device software or data, affecting confidentiality, integrity and availability of the systems and related information.
This recall is not described as part of a broader industry pattern in the provided information.
Labs may need to pause some operations to implement remediation. The recall may affect data security, system availability and workflow continuity in clinical labs.
Official recall notices on the FDA Enforcement Report page and BD’s recall communications page
Remediation timelines are determined by BD; typical replacement or remediation processes may take 4-6 weeks once initiated
Retain the recall notice, serial numbers, UDI, and all correspondence with BD for records.
Catalog Numbers: 443624, 44362409. Product: BD Phoenix M50 Automated Microbiology System. UDI/DI: 00382904436247. PF family models include PF4176, PF4182, PF2302, PF4198, PF4149, PF4189, PF4202, PF2699, PF4200, PF4207, PF4209, PF2640, PF2769, PF3383, PF2742, PF4215, PF4204, PF0571. Distribution: Worldwide. Sold: Unknown. Price: Unknown.
No injuries or incidents have been reported.
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