Medical device recalls Moderate risk

Becton Dickinson & Co. recalls BD Phoenix M50 Automated Microbiology System Version or Model: 443624 Catalog Number: 443624

Recall date
October 31, 2024
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0592-2025
FDA classification
Class II
Brand / firm
Becton Dickinson & Co.
Sold / distributed
Worldwide distribution - US Nationwide and the countries of Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Benin, Bhutan, Bolivia, Bosnia and Herzegovina, Botswana, Brazil, Brunei, Bulgaria, Burkina Faso, Burundi, Cambodia, Cameroon, Canada, Chil…

Why it was recalled

BD confirmed that 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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

BD Phoenix M50 Automated Microbiology System Version or Model: 443624 Catalog Number: 443624

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