BD BACTEC Blood Culture System, labeled as the following: 1. BACTEC 9120 System, Catalog Numbers: 445570, 445702. 2. INSTRUMENT BACTEC 9120 UNREPAIRED, Catalog Number: 44557008.

Reason: 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: 1. Catalog Number, (Serial Numbers): 445570, UDI/DI: 00382904455705 (UB4523, UB3416, UB3975, UB3871A, UB3753, UB4823, DB2572, UB4642, UB3414, UM1431, UB3731, UB1470, UB5555, UM1395, UB4212, UB3555, UB4159, UB4778, UB3805, UB1648, UB4562, UB4174, UB4325, UB1801, UB5086, UB1990, UB3103, UB4274, UB4360, UB1611, UB4535, UB4542, UB4596, UB3338, UB4688, UB3480, UB4928, UB4929, UB1439, UB1583, UB5178, UB3122, UB3335, UB3229, UB4005, UB1682, UB3541, UB3193, UB4184, UB1778, UB4405, UB3413, UB4271, UB4715, UB3210, UB4110, UB4112, UB3499, UB5405, UB5389, UB5442, UB5362, UB4995, UB1812, UB4427, UB4253, UB1708, UB3273, UM1273, UB4959, US1103, UB3383, UM1283, UM1269, UB5663, UB4384, UB5569, UB5470, UB5594, UB4185, UB5679, UB5527, UB5361, UB5579, UB4280, UB5535, UB4221, UB5596, UB5576, UB5588, UB5496, UB5610, UB3242, UB5537, UB5553, UB5565, UB5451, UB5505, UB5492, UB5507, UB5526, UB5691, UB5693, UB5694, UB5456, UB5609, UB5534, UB5631, UB5469, UB5541, UB3647, UB4048, UB4177, UB5415, UB5080, UB5529, UB5587, UB3398, UB5584, UB5414, UB5444, UB5474, UB5495, UB5523, UB5503, UB5431, UB3814, UB5550, UB5559, UB4661, UB5073, UB4776, UB5074, UB5059, UB5380, UB3491, UB4922, UB1862, UB4881, UB5093, UB2082, UB5079, UB4711, UB5101, UB5092, UB5108, UB5038, UB4704, UB4953, UB5026, UB5017, UB5110, UB5041, UB5078, UB5118, UB5598, UB5111, UB5153, UB3634, UB5149, UB5005, UB5152, UB5164, UB5129, UB5050, UB5151, UB5165, UB5158, UB9654, UB5135, UB5207, UB5195, UB5171, UB5205, UB5117, UB5229, UB5241, UB5234, UB5230, UB5140, UB5167, UB5222, UB5255, UB5063, UB5199, UB5224, UB5265, UB5136, UB5283, UB5285, UB5304, UB5060, UB5289, UB5246, UB4369, UB5309, UB5302, UB5299, UB3148, UB5235, UM1331, UB1653, UB5420, UB3654, UB5329, UB4315, UB3026, UB3336, UB1501, UB3767, UB4334, UB5373, UB5791, UB5156, UB4560, UB5300, UB4519, UB5463, UB4340, UB4244, UB5472, UB3703, UB5296, UB5457, UB5317, UB3704, UB5465, UB5393, UB4356, UB3700, UB5279, UB5130, UB5297, UB4600, UB5471, UB5479, UB4545, UB4466, UB5428, UB5488, UB3851, UB5308, UB5253, UB3483, UB5298, UB4602, UB4471, UB5339, UB3812, UB4518, UB5324, UB5381, UB4504, UB5364, UB3785, UB5397, UB4539, UB4540, UB4420, UB5358, UB5433, UB3919, UB5434, UB4481, UB5425, UB5502, UB4346, UB4507, UB5371, UB5141, UB5379, UB3320, UB4610, UB5244, UB4554, UB4567, UB4620, UB4057, UB4424, UB4634, UB5218, UB4614, UB3894, UB5316, UB5483, UB5303, UB3863, UB5374, UB4115, UB5375, UB4583, UB4114, UB4392, UB5481, UB5353, UB4581, UB4088, UB4751, UB5365, UB4666, UB1049, UB3082, UB5466, UB5360, UB1734, UB5454, UB3062, UB2013, UB1689, UB3264, UB4571, UB5412, UB4684, UM1406, UB5581, UB1555, UB5319, UB4485, UB5589, UB4653, UB5406, UB4705, UB5396, UB1746, UB4706, UB5290, UB5432, UB4572, UB4117, UB4745, UB5543, UB4175, UB5514, UB5604, UB4730, UB3907, UB5372, UB4719, UB4681, UB4162, UB5245, UB4768, UB5388, UB4483, UB4718, UB5119, UB4139, UB5301, UB4232, UB5367, UB4723, UB5125, UB5382, UB5142, UB4747, UB3489, UB4641, UB4618, UB5061, UB4633, UB4817, UB4638, UB5418, UB4226, UB5417, UB4835, UB4643, UB4809, UB5262, UB5221, UB5422, UB5551, UB5261, UB4834, UB4756, UB4838, UB4812, UB4766, UB4810, UB4826, UB5621, UB4781, UB4861, UB4856, UB4859, UB4876, UB4854, UB5620, UB5540, UB4860, UB5538, UB4765, UB5560, UB5506, UB4755, UB5530, UB5585, UB5574, UB4902, UB4888, UB4886, UB3237, UB4870, UB4914, UB4880, UB4901, UB4906, UB4935, UB4932, UB4805, UB4917, UB4934, UB4918, UB4955, UB4905, UB4956, UB4944, UB4963, UB4916, UB4964, UB4969, UB4806, UB4979, UB4983, UB4135, UB5030, UB5013, UB4994, UB5004, UB5034, UB5020, UB4374, UB4478, UB4612, UB4651, UB4738, UB3718, UB3811, UB4463, UB3865, UB3868, UB3877, UB3878, UB3911, UB3914, UB3915, UB5636, UB5638, UB5640, UB5642, UB5641, UB3940, UB5646, UB5650, UB5654, UB1248, UB9256, UB5347, UB5345, UM1239, UB1792, UB0031, UB3709, UB4740, UB4732, UB3479, UB1793, UB1750, UB1057, UB1609, UB3853, UB3205, UB3448, UB3539, UB3779, UM1180, UM1201, UB0097, UM1345, UM2069, UB1048, UB3696, UB5102, UB5209, UB5607, UB3655, UB5561, UB5517, UB4461, UB5180, UB3948, UB3852, UB3984, UB3265, UB5036, UB4930, UB1671, UM1403, UB3952, UB5668, UB5015, UB4899, UB4129, UB4093, UB4894, UB4981, UB4147, UB5133, US1048, UB4260, UB4587, UB3275, UB4565, UB5268, UB5392, UB5453, UB4986, UB4475, UB5387, UB5196, UB5042, UB5443, UB5210, UB3813, UB3658, UB5223, UB4637, UB3561, UB5459, UB4201, UB4703, UB3013, UB4052, UB1977, UB5132, UB5064, UB5175, UB5247, UB4419, UB4862, UB4866, UB5557, NB3896, UB5292, UB4412, UB3553, UB4700, UB1672, UB4489, UB4491, UB5404, UB5002, UB4113, UB4487, UB3876, UB4259, UB1657, UB3170, UB1892, UB1925, UB4658, UB1716, UB5105, UB3010, UB4379, UB5021, UB3259, UB1891, UB1668, UB1878, UB5344, UB5342, UB5512, UB5441, UB5137, UB5052, UB3721, UB2051, UB5286, UB3396, UB4181, UB3950, UB5024, UB4394, UB5661, UB5662, UB5511, UB5563, UB5675, UB1553, UB5623, UB5508, UB5676, UB5608, UB5685, UB5447, UB5546, UB5341, UB5409, UB5438, UB5318, UB5577, UB5413, UB5625, UB5522, UB5545, UB5570, UB5627, UB5595, UB5485, UB5352, UB5462, UB5572, UB5612, UB3745, UB5593, UB5548, UB5619, UB5700, UB5586, UB5567, UB5582, UB5583, UB5439, UB5613, UB5578, UB5532, UB5562, UB5599, UB5571, UB5615, UB5558, UB5519, UB5590, UB4043, UB4220, UB5084, UB5057, UB5043, UB5053, UB5076, UB5087, UB5071, UB5099, UB5068, UB5077, UB5098, UB5066, UB5029, UB5070, UB5094, UB5045, UB5095, UB5122, UB5085, UB5022, UB4977, UB5104, UB5116, UB5124, UB5072, UB5120, UB5138, UB5145, UB5147, UB5155, UB5157, UB5169, UB5170, UB8041, UB5168, UB5146, UB5143, UB5096, UB4731, UB4904, UB5160, UB5106, UB5201, UB5197, UB5618, UB5154, UB5225, UB5243, UB5206, UB5212, UB4873, UB4631, UB5254, UB5267, UB5184, UB5211, UB5203, UB5194, UB5240, UB5219, UB5677, UB5277, UB5148, UB5242, UB5294, UB5239, UB5275, UB5131, UB5305, UB5295, UB5326, UB5573, UB5282, UB5368, UB3055, UB5385, UB3570, UB5270, UB5314, UB3042, UB5323, UB3493, UB5461, UB5429, UB4231, UB3636, UB3706, UB1934, UB3424, UB4245, UB5313, UB5359, UB5284, UB5416, UB5458, UB5260, UB5467, UB4333, UB4354, UB5435, UB4339, UB4872, UB5306, UB4342, UB5272, UB3768, UB5159, UB4355, UB5338, UB5202, UB4423, UB5516, UB5486, UB5327, UB5370, UB3800, UB4438, UB5320, UB5348, UB4205, UB3750, UB4505, UB5322, UB5307, UB5357, UB3771, UB5256, UB4410, UB4510, UB5331, UB5424, UB5489, UB4566, UB5123, UB4011, UB5408, UB4553, UB3350, UB4068, UB4486, UB4558, UB4070, UB5264, UB4083, UB5334, UB4503, UB4482, UB4498, UB5377, UB4555, UB5494, UB5177, UB5355, UB4648, UB4116, UB5500, UB4474, UB4680, UB5293, UB4720, UB5335, UB5291, UB5468, UB4773, UB5473, UB4102, UB5198, UB5455, UB5399, UB5259, UB4178, UB4685, UB4721, UB5386, UB5366, UB4105, UB4758, UB4775, UB4764, UB5491, UB5515, UB5448, UB4743, UB4759, UB5501, UB5394, UB5449, UB4464, UB5419, UB5346, UB4686, UB4163, UB5263, UB4225, UB5407, UB4763, UB5310, UB5340, UB5450, UB4767, UB5332, UB4237, UB5383, UB5333, UB4761, UB4782, UB4422, UB4871, UB5232, UB5351, UB4821, UB4671, UB5069, UB5597, UB4807, UB5547, UB4837, UB4804, UB5611, UB5464, UB5624, UB5436, UB5552, UB5549, UB4855, UB4878, UB4748, UB5518, UB5564, UB5440, UB4762, UB5498, UB4892, UB4462, UB5437, UB4885, UB4780, UB5112, UB4848, UB5065, UB5173, UB4779, UB4879, UB5533, UB4889, UB5524, UB4887, UB4852, UB4909, UB4882, UB4717, UB4948, UB4936, UB4939, UB4942, UB4853, UB4839, UB4744, UB4836, UB4891, UB4777, UB4954, UB2083, UB4884, UB4808, UB3132, UB4774, UB4965, UB4957, UB4403, UB4933, UB3680, UB4968, UB4984, UB4989, UB4679, UB4940, UB4769, UB2027, UB4198, UB4970, UB5037, UB5031, UB4982, UB5018, UB5014, UB4985, UB5044, UB4927, UB3432, UB4608, UB4632, UB4644, UB1983, UB4084, UB5602, UB5614, UB5622, UB5616, UB5634, UB3912, UB5630, UB3929, UB5645, UB5643, UB5649, UB5651, UB5653, UB5655, UB4064, UB2126, UB3304, UB3366, UB3481, UB4913, UM1179, UM1730, US1113, UB3440, UB4047, UB4261, UB4456, UB4425, UB4497, UB4820, UB4911, UB3452, UB1458, UB3482, UB6515, UB4173, UB4534, UB4662, UB1952, UM5032, UB4381, UB4363, UB4515, UB4692, UB4695, UB4365, UB4273, UB4603, UB4657, UB1629, UB4697, UB4582, UB1673, UB4303, UM1350, UB1697, UB4530, UB4490, UB4577, UB4598, UB4561, UB4604, UB4592, UB3677, UB3065, UB4296, UB4750, UB4771, UB3770, UB3992, UB3971, UB3964, UB4050, UB3976, UB4868, UB4059, UB4101, UB1622, UB4617, UB1519, UB3004, UB1813, UB4298, UB1912, UB4179, UB3286, UB3299, UB4209, UB4432, UB1915, UB4263, UB3310, UB4211, UB4270, UB2076, UB3023, UB3197, UB3411, UB3157, UB2026, UB2022, UB4319, UB3324, UB1893, UB3333, UB4429, UB1713, UB4233, UB3296, UB3272, UB3225, UB2078, UB3377, UB3236, UB3332, UB4446, UB3648, UB4707, UB3551, UB3513, UB4712, UB4401, UB3303, UB3317, UB4343, UB4945, UB5249, UB5010), 445702, UDI/DI: 00382904457020, (UB4002A, UB3795, UB4188, UB4006, UB1523, UB3123, UB4154B, UB3139, UB3191, UB3595, UB3409, US1125, UB4347, UB4351, UB3946A, UB4587A, UB3318, UB3007, UB1474, UB4285, UB4118, UB4670, UB4621, UB4301, UB3445). 2. Catalog Number: 44557008, UDI/DI: 00382904455705, serial numbers (UB4073, UB4358).

Distribution pattern: 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.