Device product
BD COR GX Instrument Version or Model: 443990 Catalog Number: 443990
Z-0589-2025
Product summary
- Event
- Event 95636
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 70 units (7 US, 63 OUS)
- Official record key
device-enforcement:Z-0589-2025
Official wording
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.
Code information: Catalog No: 443990; UDI-DI: 00382904439903; Serial Numbers: CRG0023, CRG0041, CRG0115, CRG0040, CRG0106, CRG0110, CRG0112, CRG0109, CRG0047, CRG0120, CRG0039, CRG0113, CRG0035, CRG0037, CRG0036, VGT0009, CRG0020, CRG0002, VGX0004, CRG0007, CRG0008, CRG0104, CRG0018, CRG0019, CRG0045, CRG0029, CRG0028, CRG0030, CRG0201, CRG0203, CRG0021, CRG0004, CRG0005, CRG0006, CRG0009, CRG0010, CRG0012, CRG0011, CRG0013, CRG0014, CRG0025, CRG0015, CRG0016, CRG0017, CRG0026, CRG0027, CRG0107, CRG0101, CRG0105, CRG0108, CRG0114, CRG0116, CRG0117, CRG0119, CRG0118, CRG0034, CRG0044, CRG0001, CRG0003, CRG0032, CRG0038, CRG0043, CRG0042, CRG0102, CRG0111, CRG0048, CRG0103, CRG0121, CRG0204, CRG0207,
Distribution pattern: 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, China, Colombia, Costa Rica, Cote d'Ivoire, Croatia, Cyprus, Czech Republic, Democratic Republic of the Congo, Denmark, DOM, Dominica, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Ethiopia, Faroe Islands, Fiji, Finland, France, French Guiana, Gambia, Georgia, Germany, Ghana, Greece, Guadeloupe, Guam, Guatemala, Guinea, Guyana, Haiti, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Jamaica Japan, Jordan, Kazakhstan, Kenya, Kosovo, Kuwait, Kyrgyzstan, Laos, Latvia, Lebanon Liberia, Libyan Arab Jamahiriya, Liechtenstein, Lithuania, Luxembourg, Macau, Madagascar Malawi, Malaysia, Maldives, Mali, Malta, Martinique, Mauritania, Mauritius, Mayotte Mexico, MKD, Moldova, Mongolia, Morocco, Mozambique, Namibia, Nepal, Netherlands Antilles, New Caledonia, New Zealand, Nicaragua, Nigeria, Northern Mariana Islands, Norway, Oman, Pakistan, Panama, Papua new Guinea, Paraguay, Peru, Philippines PNG, Poland, Portugal, Puerto Rico, Qatar, Reunion, Romania, Russia, Rwanda, Saint Helena San Marino, Saudi Arabia, Senegal, Serbia, Seychelles, Sierra Leone, Singapore, Slovakia Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Swaziland, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Tajikistan, Tanzania, United Republic of Thailand, Timor-Leste, Tonga, Trinidad And Tobago, Tunisia, Turkey, Turkmenistan Uganda, Ukraine, United Arab Emirates, United Kingdom, Uruguay Uzbekistan, Vietnam, Yemen, Zambia, Zimbabwe.
Derived failure modes
-
Unknown
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.