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

Summary

The FDA issued a Class II for BD MAX System, BD MAX Instrument Version or Model: 441916 Catalog Number: 4419 by Becton Dickinson & Co.. Reason: BD confirmed that product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized a.

Details

Product Description

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

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, CT0667, 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CM0014, MX0055, EP0005, CM0031, MX0054, CM0017, CM0033, CT0599, CT0601, CT0602, CT0604, CT0603, CT0365, CT0638, CT0426, CT0911, CM0010, CT0788, CT0787, CT0635, CT0597, CT0633, CT0915, CT0793, MX0031, CT0178, CT0743, CT0768, CT0782, CT0780, CT0783, CT0744, CT0745, CT0767, CT0766, CT0737, CT0748, CT0751, CT0763, CT0776, CT0953, CT0957, CT0945, CT0964, CT0973, CT1048, CT0983, PP0005, CT0997, CT0994, CT0746, CT0999, CT1003, CT1005, CT1014, CM0032, CT1021, CT1020, CT1019, CT1062, CT1058, CT1067, CT1083, CT1091, CT1080, CT1105, CT1112, CT2384, CT2385, CR0589, CT2632, CT2636, CT2629, CT2646, CT2638, CT2663, CT2668, CT2647, CT2393, CT2398, CT2498, CT2504, CT2517, CT2433, CT2515, CT2513, CT2507, CT2532, CT2520, CT2543, CT2547, CT2569, CT2575, CT2528, CT2587, CT2583, CT2526, CT2621, CT2594, CT2604, CT2597, CT2441, CT2627, CT2634, CT2651, CT3122, CT3132, CT3146, CT3156, CT3166, CT3169, CT2376, CT2375, CT3023, CT3043, CT3045, CT3049, CT3064, CT3065, CT3057, CT3062, CT3071, CT3099, CT3100, CT3107, CT2664, CT2648, CT2671, CT2681, CT3009, CT3010, CT3007, CT3178, CT3179, CT3186, CT3167, CT3281, CT3261, CT3283, CT3271, CT3207, CT3226, CT3241, CT3230, CT3234, CT3239, CT3240, CT3251, CT3249, CT3312, CT3325, CT3319, CT3295, CT3335, CT3341, CT3322, CT3343, CT3345, CT3350, CT3351, CT3360, CT3371, CT3382, CT3374, CT3380, CT3388, CT3397, CT3408, CT1647, CT2005, ct2322, CT2337, CT2305, CT2611, CT3123, CT1193, CT0948, CT0658, CT0388, CT0676,

Quantity Affected: 2,537 units (876 US, 1,661 OUS)

Reason for Recall

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.

Type: Voluntary: Firm initiated

Recall Initiated: 2024-10-31

Company