—#210855

Product

BD MAX System, BD MAX Instrument Version or Model: 441916 Catalog Number: 441916

FDA product code: OZN — C. Difficile Toxin Gene Amplification Assay
Device class: Class 2
Medical specialty: Microbiology
510(k) numbers: K111860, K120138, K130470
Affected lot / code info: Catalog No: 441916; UDI-DI: 00382904419165; Serial Numbers: CT1777, CT1168, CT1902, CT2015, CT1939, CT2084, CT2113, CT2216, CT2191, CT1972, CT1175, CT2157, CT2698, CT3324, CT1174, CT0849, CT1186, CM0122, CT2368, CT2483, CT3267, CT2423, CT2437, CT1187, CT1184, CT2405, CT2558, CT3126, CT2710, CT0838, CT2565, CT0841, CT2570, CT1203, CT2573, CT2606, CT2709, CT2670, CT2708, CT2691, CT3184, CT1753, CT2108, CT3192, CT1914, CT3173, CT3193, CT3301, CT3328, CT1316, CT3355, CT1227, CM0046, CT2478, CT1298, MX0057, CT1299, MX0059, MX0045, CT1819, CT0285, CM0041, CT1306, CT1324, CT1321, CT0137, CM0070, CT1330, CT0216, CM0064, CM0123, CT3291, CT1338, CT0171, CT0201, CT0164, CT1341, CT1346, CT0246, CT0387, 1000094, CT1642, CT1839, CT1995, CT2470, CT0971, CT0701, CT0276, CM0075, CT0296, CT0299, CT0308, CT1275, CT1682, CT1345, CT2202, CT0464, CT2496, CT0706, CT2505, CT2479, CT1348, CT0977, CT0688, CM0074, CT0340, CT1670, CT0297, CT1698, CT0920, CT2705, CT2639, CT0386, CT1684, 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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.

Root cause (FDA determination)

Software design

Action the firm took

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, isolate affected devices in a secure VLAN or behind firewalls with restrictedaccess that only permits communication with trusted hosts in other networks when needed "Impacted devices do not require use of RDP ports and these should be disabled or blockedif enabled "Ensure permissions on file shares are appropriately established and enforced, and monitorand log access for evidence of suspicious activity "Disconnect devices from the network if connectivity is not necessary Next Steps to be Taken by Customer: 1.Ensure the contents of this notification are read and understood. 2.Share and post this customer letter within your facility network including IT and safety andsecurity department. Forward to any customers to whom you may have distributed theproduct(s) to ensure awareness. 3.Complete the attached Customer Response Form and return it to the BD contact noted on theForm so that BD may acknowledge your receipt of this notification per FDA requirements. 4.Report any adverse health consequences experienced with the use of these products to BD.Events may also be reported to the FDA's MedWatch Adverse Event Reporting program via: Web: MedWatch website at www.fda.gov/medwatch Phone: 1-800-FDA-1088 (1-800-332-1088) Mail: MedWatch, HF-2, FDA, 5600 Fisher s Lane, Rockville, MD 20852-9787 If you require further assistance, please contact: Technical Service +1 888 451 5514 Technical Questi

Recalling firm

Firm: Becton Dickinson & Co.
Address: 7 Loveton Cir, Sparks, Maryland 21152-9212

Distribution

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.

Timeline

Recall initiated: 2024-10-31
Posted by FDA: 2024-12-03
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #210855. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.