FDAFDA · Food and drugs·Recall number Z-0592-2025
BD Phoenix M50 Automated Microbiology System Version or Model: 443624 Catalog Number: 443624
Published December 11, 2024 · Recall initiated: October 31, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Becton Dickinson & Co.
- Distributor
- 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.
- Lot
- Catalog No: 443624; UDI-DI:00382904436247; Serial Numbers: PF4176, PF4182, PF2302, PF4198, PF4149, PF4189, PF4202, PF2699, PF4200, PF4207, PF4209, PF2704, PF2640, PF2769, PF3383, PF2742, PF5292, PF4215, PF4204, PF0571, PF4188, PF4216, PF1642, PF4231, PF0929, PF4240, PF3443, PF0934, PF4232, PF4212, PF0566, PF3126, PF5408, PF5436, PF1716, PF5384, PF5396, PF5398, PF5404, PF3345, PF5443, PF3203, PF3128, PF0598, PF3447, PF0601, PF5489, PF5495, PF5022, PF5063, PF3362, PF3340, PF5459, PF5492, PF5462, PF5499, PF0703, PF5466, PF0880, PF0705, PF5525, PF5469, PF5471, PF3397, PF4309, PF4397, PF5547, PF0632, PF0638, PF4443, PF0637, PF5200, PF5549, PF5202, PF5550, PF0643, PF5049, PF0639, PF3204, PF5207, PF5094, PF5209, PF5117, PF1352, PF5217, PF5148, PF5231, PF5195, PF5097, PF5162, PF5109, PF5169, PF5179, PF5183, PF2063, PF5197, PF5203, PF5168, PF5323, PF5329, PF0687, PF5352, PF5353, PF5418, PF5350, PF2796, PF5359, PF5227, PF3169, PF5351, PF5365, PF5218, PF5361, PF5389, PF5265, PF5266, PF5328, PF5337, PF2274, PF0707, PF6126, PF0718, PF5356, PF5403, PF6167, PF5027, PF5349, PF5371, PF6174, PF4049, PF4071, PF4444, PF4064, PF4292, PF4305, PF4306, PF4315, PF4317, PF5042, PF4285, PF4287, PF4304, PF4373, PF4376, PF4407, PF4297, PF5043, PF4294, PF5072, PF5082, PF4251, PF4254, PF4393, PF4394, PF1032, PF5140, PF4252, PF5143, PF4253, PF5144, PF4335, PF4379, PF4390, PF4419, PF4308, PF5414, PF4295, PF5431, PF4337, PF4100, PF4415, PF4420, PF1054, PF2590, PF4346, PF5633, PF4278, PF4439, PF5874, PF5877, PF4338, PF4436, PF4430, PF5887, PF5011, PF5024, PF5048, PF5790, PF1478, PF1483, PF5047, PF4406, PF5134, PF1932, PF5021, PF5947, PF5029, PF5050, PF5130, PF5142, PF5145, PF5156, PF4412, PF1481, PF1091, PF5125, PF1096, PF5129, PF1099, PF5135, PF5088, PF1154, PF5108, PF1305, PF5164, PF6098, PF5111, PF1298, PF1373, PF1387, PF5153, PF6304, PF1477, PF6305, PF1513, PF6307, PF1743, PF5058, PF5064, PF5087, PF5078, PF0575, PF0534, PF0828, PF0928, PF5013, PF0672, PF0673, PF0675, PF1969, PF0429, PF1497, PF0533, PF2269, PF0633, PF5051, PF0841, PF1011, PF0719, PF0721, PF0737, PF0758, PF5107, PF5275, PF5493, PF5518, PF5163, PF0306, PF5472, PF0409, PF5494, PF5508, PF5509, PF5517, PF5521, PF0463, PF5522, PF2316, PF5527, PF2299, PF1124, PF0468, PF2407, PF0515, PF0628, PF0630, PF5582, PF0626, PF0879, PF0677, PF1112, PF5257, PF0541, PF0794, PF1122, PF1119, PF5548, PF1001, PF5555, PF0984, PF5561, PF5571, PF5572, PF5575, PF5589, PF5591, PF2200, PF5594, PF2202, PF5598, PF2096, PF5599, PF0004, PF1569, PF1045, PF1662, PF1405, PF1641, PF1412, PF1414, PF2003, PF2132, PF2223, PF2324, PF1528, PF1147, PF2369, PF2653, PF2561, PF5608, PF5611, PF2697, PF2268, PF1153, PF2546, PF0197, PF0199, PF0268, PF5733, PF5270, PF4099, PF4172, PF5613, PF0493, PF0494, PF0496, PF5957, PF1196, PF5966, PF1189, PF1195, PF1188, PF1192, PF0082, PF1202, PF0085, PF1201, PF1207, PF1206, PF1214, PF1191, PF1229, PF1230, PF1231, PF0614, PF0275, PF0190, PF0273, PF1257, PF1262, PF1063, PF1062, PF2379, PF0792, PF1208, PF0938, PF0942, PF1376, PF1384, PF1386, PF1390, PF0097, PF0094, PF0096, PF1408, PF0165, PF1285, PF0214, PF2360, PF2068, PF0307, PF2393, PF4056, PF2406, PF4017, PF3368, PF3197, PF3059, PF1354, PF1410, PF2564, PF1425, PF5173, PF5254, PF3412, PF4238, PF1430, PF1432, PF4384, PF1434, PF4223, PF4222, PF1417, PF0612, PF1422, PF1396, PF5832, PF0065, PF5833, PF0071, PF5862, PF5869, PF5822, PF0264, PF5825, PF3147, PF1507, PF5829, PF1423, PF5821, PF1427, PF5818, PF5830, PF5860, PF5861, PF1452, PF1437, PF0232, PF5693, PF1436, PF5682, PF2480, PF1508, PF1517, PF0751, PF1566, PF1720, PF6189, PF6171, PF6243, PF6254, PF6175, PF5240, PF2426, PF1582, PF2306, PF0319, PF0322, PF4325, PF1626, PF5480, PF1627, PF1752, PF1748, PF0917, PF1527, PF1531, PF0318, PF1816, PF0892, PF1537, PF1309, PF1539, PF0205, PF1371, PF1450, PF1451, PF1791, PF2236, PF2130, PF0013, PF2374, PF0023, PF0025, PF0028, PF0038, PF1591, PF1951, PF0034, PF1607, PF2752, PF1603, PF2760, PF0049, PF0054, PF4195, PF1630, PF1631, PF2975, PF3253, PF4068, PF5302, PF532
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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