Recall Z-0593-2025 ยท MDB System, Blood Culturing
Becton Dickinson & Co.
BD BACTEC FX, Instrument Top, Packaged Version or Model: 441385 Catalog Number: 441385
| Date | Dec 3, 2024 (initiated Oct 31, 2024) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Software design |
| Action | On October 31, 2024 URGENT" MEDICAL DEVICE PRODUCT CORRECTION letters were sent to consignees. IT, Safety and Security Actions to be Taken: BD encourages customers to follow best practices for maintaining strong security measures to protect hospital networks and medical devices including: "Ensure access to potentially vulnerable devices is limited to authorized personnel "Inform authorized users of issue, and ensure all relevant passwords are tightly controlled "Monitor and log network traffic attempting to reach medical device managementenvironments for suspicious activity "Where possible, is |
| Quantity | 10,129 units (2,836 US, 7,293 OUS) |
| Distribution | 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, Chile |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K915796 | BACTEC 9240 SYSTEM Bd Becton Dickinson Vacutainer Systems Preanalytic, Apr 22, 1992 |