BD BACTEC Blood Culture System, labeled as the following: 1. BD BACTEC FX, Instrument Top, Packaged, Catalog Number: 44138509. 2. Instrument Top Remanufactured Bactec Fx, Catalog Number: 441676. 3. BACTEC 9240 System, Catalog Number: 445569. 4. BD BACTEC FX40 Instrument, Catalog Number: 44229609.
Enforcement
- Recall Number
- Z-0236-2026
- Event ID
- 97479
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Becton Dickinson & Co.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Report Date
- October 29, 2025
- Initiation Date
- September 23, 2025
- Classification Date
- October 23, 2025
- Address
- 7 Loveton Cir, Sparks, MD, 21152-9212, United States
Description
BD BACTEC Blood Culture System, labeled as the following: 1. BD BACTEC FX, Instrument Top, Packaged, Catalog Number: 44138509. 2. Instrument Top Remanufactured Bactec Fx, Catalog Number: 441676. 3. BACTEC 9240 System, Catalog Number: 445569. 4. BD BACTEC FX40 Instrument, Catalog Number: 44229609.
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.
1. Catalog Number: 44138509; UDI/DI: 00382904413859; Serial Numbers: FT5675, FT5497, FT4948, FT5781, FT5120, FT3993, FT7779, FT3387, FT1993, FT5019, FT9109, FT8412, FT7176, FT7344, FT4282, FT7400, FT6093, FT0962, FT2780, FT0795, FT0794, FT2799, FT5924, FT5279, FT5286, FT0572, FT4931, FT7289, FT9801, FT2652, FT5232, FT1348, FT8083, FT0640, FT7159, FT7034, FT8410, FT0098, FT2650, FT6203, FT3480, FT4917, FT3031, FT3033, FT4902, FT7189. 2. Catalog Number: 441676; UDI/DI: 00382904416768; Serial Numbers: FT7439A, FT7201A, FT5679, FT0599, FT0598, FT0644, FT0600, FT5025, FT2845, FT0525, FT0715, FT4439, FT0330, FT2313, FT3020, FT3022, FT0745, FT5090, FT4340, FT6225, FT4977, FT0571, FT0570, FT0498, FT5248, FT5270, FT3537, FT4448, FT3538, FT3486, FT0340, FT1517, FT5590, FT3030, FT4800, FT1774, FT2263, FT5014, FT5013, FT7184A. 3. Catalog Number: 445569; UDI/DI: 00382904455699; Serial Numbers: DB4372, DB6043, DB5030, DB5825, DB2835, DB3251, DB3245, DB3145, DB5876, DB5906, DB3143, DB3204, DB6891, PM4385R, DB4718, DB3231, DB2786, DB6628, DB6393, DB6936, DB4987, DB5347A, DB6123, DB6281, DB6933, DB6451, DB5602, DB5858, DB4763, DB6302, DB6165, DB5596, DB5089, DB7157, DB5021, DB3086, DB4776, DB6296, DB5328, DB2245, DB2483, DB5329, DB2946, DB2945, DB4348, DB5319, DB4299, DB4484, MD2033, DB3062, RC1164, DB6323, DB4550, DB6213, DB5083, DB6383, DB6381, DB6457, DB6169, DB6212, DB6929, DB6978, DB6913, DB6540, DB6699, DB6989. 4. Catalog Number: 44229609; UDI/DI: 00382904422967; Serial Numbers: FF1979, FF0713, FF0410, FF1561, FF2832, FF4395, FF1500, FF0697, FF0933, FF1499, FF1025, FF5511, FF0027, FF1118, FF3195, FF0115, FF5979, FF6535, FF0391, FF3284, FF0772, FF0570, FF0638, FF1599, FF1271.
Worldwide distribution. US Nationwide including Guam and Puerto Rico, Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bosnia and Herzegovina, Botswana, Brazil, Bulgaria, Burkina Faso, Burundi, Cambodia, Canada, Chile, China, Colombia, Costa Rica, Cote d'Ivoire, Croatia, Cyprus, Czech Republic, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Ethiopia, Finland, France, French Guiana, Georgia, Germany, Ghana, Greece, Guatemala, Guinea, Honduras, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kuwait, Lebanon, Libyan Arab Jamahiriya, Lithuania, Luxembourg, Malaysia, Mali, Malta, Mauritania, Mauritius, Mexico, Mongolia, Morocco, Nepal, Netherlands, New Zealand, Nigeria, Norway, Oman, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russia, Rwanda, Saudi Arabia, Senegal, Serbia, Sierra Leone, Singapore, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Timor-Leste, Trinidad and Tobago, Tunisia, Turkey, Uganda, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Vietnam, Zambia, and Zimbabwe.
177 units