MagNA Pure LC 1.0 (software version 3.0.11). Roche Diagnostics Operations, Inc. An automated instrument used for isolation of nucleic acids (DNA, total RNA, total viral nucleic acids) from different kinds of biological research sample material (whole blood, serum, blood cells, culture cells, tissue, bacteria, fungi) using the specially designed MagNA Pure LC kits, for the purpose of life science research only and automated filling of different kinds of PCR reaction vessels (LightCycler Capillar
Hazard
Roche has detected a problem with the MagNA Pure LC 1.0 (software version 3.0.11) and the MagNA Pure LC 2.0 (software versions 1.1.23 and 1.1.24) instruments. Under certain circumstances, only a fraction of each sample is processed which may lead to false negative results, and an impact to patient health if used in a homebrew diagnostic application.
What You Should Do
Remedy
Roche Diagnostics Operations, Inc. sent a letter dated July 21, 2011 entitled "URGENT MEDICAL DEVICE CORRECTION" to all affected customers. The letter included the name product, software versions, and reason for recall and informed them the problem is under investigation. In the meantime, customers are asked to wait 30 seconds after the finalization of the decontamination cycle before initiating the next operation, in order to avoid this issue. For questions on this recall please call Roche at (800) 428-5074.
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Products
MagNA Pure LC 1.0 (software version 3.0.11).
Roche Diagnostics Operations, Inc.
An automated instrument used for isolation of nucleic acids (DNA, total RNA, total viral nucleic acids) from different
- Brand
- Roche Diagnostics Operations, Inc.
- UPC
- Series 1.0 software version 3.0.11, Part number 12236931001, Ser Numbers 28KN9Z70VE, LCPG0398, US03910905, US94800252, LCPD0020, LCPF0163, LCPG1291, LCPG1291, MXL5040CBZ, LCPE0042, CZC5252BDQ, LCPG1314, 2UA40207G6, LCPG0723, FRB3270KYX, LCPG0876, CZC5240354, US14111136, LCPG0426, USC326024W, LCPG0627, 29KN9ZP27C, LCPG0492, FRB3270H1D, LCPG0952, 2UA402049J, LCPG0711, LCPG0431, LCPG1070, LCPG0431, LCPG1070, USC3260241, USC3260241, CZC52403GR, CZC52403GR, CZC5252BDC, CZC5252BDC, LCPG0613, LCPG0613, LCPG1041, LCPG1041, CZC5251H2N, FRB3270JV7, FRB3270L5Y, LCPG0955, LCPG0956, 70018557, LCPG1252, FRB3270LQJ, LCPG0976, FRB3270KCK, LCPG0950, US14111105, CZC5231GH2, LCPG0320, LCPG1143, 2UA33504CM, LCPG0654, 2UB3370CMH, LCPG0689, 2UA4110GFH, MXL5310FQ7, CZC5251H5Z, LCPG0807, LCPG1161, LCPG1290, LCPG1290, US14110908, CZC5251G3F, LCPG0244, US10570146, CZC52402Y9, LCPF0131, US03910992, LCPF0178, USC325070Z, USU32703WY, LCPG0629, LCPG0663, USU32703WZ, LCPG0664, 28KN9ZK0Y9, CZC5252B9Z, LCPG0427, CZC521G1L, LCPG1071, FRB3270LQL, LCPG0983, LCPG1176, FRB3270LQT, LCPG1272, LCPG0973, 2AKN9Z0EM, LCPG0447, MXL4390NJC, LCPG0768, USC3250712, LCPG0626, 28KN9Z7039, US10570100, US13804158, US94800391, CZC5252BGI, LCPE0041, LCPF0128, LCPG0310, LCPG0432, FRB3270L25, LCPG0761, 51KN9ZE957, LCPG0524, US14110777, LCPG0418, US14110777, LCPG0418, LCPG1268, CZC5251GCB, US04552506, LCPF0165, LCPF0165, FRB3270G5Z, LCPG0942, 28KN9ZL0MV, USC3220T8R, LCPG1045, FRB3270LSD, LCPG0982, FRB3270LSD, LCPG0982, CZC52403GM, LCPG1033, 429000KH, LCPG0894, 70018555, 70018230, LCPG1226, CZC524038J, LCPG1042, LCPG1152, 2UA33503SQ, LCPG0637, 2UA33503SQ, LCPG0637, 2UA33503SQ, LCPG0637, FRB32806ZY, LCPG0772, US14111131, LCPG0393, MXL4390NJB, LCPG0881, MXL4360D21, US14110727, SCZC52529XT, LCPG0306, FRB3270L1D, LCPG0842, 2UA43304Z2, LCPG0801, LCPG1292, LCPG1128, 2UB42002SG, CZC5252BHC, FRB32806D7, SVC1, LCPG0812, LCPG0930, LCPG0762, LCPG1306, 51KN9ZE943, LCPG0468, 2UA412033Z, 2UB33709S5, CZC5231GKS, FRB3270KYV, LCPG0875, 2UA412033Z, 2UB33709S5, CZC5231GKS, FRB3270KYV, LCPG0739, LCPG0740, LCPG0875, 2UB3370CRC, MXL4390NFJ, LCPG0769, LCPG0638, LCPG1036, CZC523187N, LCPG0294, MXL4360D1V, MXL4390NGT, USC326023Y, CZC5231FX5, CZC524035H, CZC5252B7K, CZC5252BOP, LCPG0572, LCPG0790, LCPG0791, LCPG1062, LCPG1162, LCPG1315, LCPG1318, FRB328070C, US14110905, CZC5240316, LCPG0396, LCPG1237, 2UB3370C62, LCPG0544, 29KN9ZP257, LCPG0537, US11303448, LCPG0252, FRB3270L0V, FRB3270L6P, LCPG0987, LCPG0932, FRB3270L1G, 2UA4020LMG, US04552507, LCPF0162, LCPF0162, LCPG0725, LCPG0725, 2UA431044W, CZC5257GHS, FRB32806CW, LCPG0411, LCPG0988, LCPG1037, 2UB3370CPR, US14111094, LCPG0399, LCPG0399, USU32703XT, 70018561, CZC5251GD5, CZC5252B76, LCPG0667, USC3220TSM, CZC5252BCV, LCPG0625, LCPG1069, 51KN9ZE964, LCPG0528, 2UB42002RV, LCPG0809, FRB3270LV3, LCPG0844, 2UB423087N, MXL4360CZS, USC325070H, 70018262, 70018263, 70018264, 70018558, 70018559, 70018560, LCPG0425, LCPG0634, LCPF0136, LCPF0136, LCPF0136, LCPG0265, LCPG0421, LCPG0421, LCPG0425, LCPG0425, LCPG0634, LCPG0634, LCPG0803, LCPG0803, FRB328070L, LCPF0136, LCPG0265, LCPG0421, LCPG0425, LCPG0634, LCPG0634, LCPG0803, LCPG0879, SCZC5252B5W, LCPG1321, LCPG1289, CZC5252BFR, LCPG00001289, 2UA4020483, LCPG0726, LCPG1032, CZC52403GH, LCPG1032, 429000KR, CZC5251G3L, CZC5251GSM, CZC5252B2Q, LCPG0893, LCPG1172, 28KN9ZX0T3, MXL4390NJ1, MXL4390NJ1, US04552482, US04552482, US13053013, US13053013, CZC5240314, CZC5252BCC, CZC525GZK, CZC525GZK, FRB3270L1V, FRB3270L1V, LCPF0173, LCPF0173, LCPG0293, LCPG0293, LCPG0376, LCPG0718, LCPG0718, LCPG0934, LCPG0934, LCPG1067, LCPG1067, LCPG1129, LCPG1129, LCPG1139, LCPG1139, LCPG1239, LCPG1239, LCPG1307, LCPG1307, LCPG1322, LCPG1324, LCPG1326, USW3190C0K, FRB3270L5V, LCPG0576, LCPG0971, 29KN9ZP1EE, LCPG0488, 51KN9ZE919, MXL4420B96, LCPG0895, FRB3270L0W, LCPG0864, CZC5252B9H, LCPG1282, 2UB3370B15, CZC52403GC, LCPG0730, LCPG1027, 2UA4020LFK, LCPG0641, FRB3270L09, LCPG0758, USC326023W, LCPG0631, 28KN9ZP0T0, LCPG0386, USU32703Y3, USU32703Y3, FRB3270LQR, FRB32806GB, LCPG0972, 2UB3370CQK, 2UB33803P7, CZC52529Z3, LCPG0669, FRB328072N, LCPG0891, MXL4420B9X, LCPG0901, 51KN9ZE929, LCPG0526, LCPG1288, 28KN9Z70VB, 2UB3370C1Z, 2UB3370CJZ, MXL4360D1N, MXL4390NGV, MXL4390NH1, MXL4390NJD, US14110846, LCPG0281, LCPG0373, LCPG0557, LCPG0566, LCPG0759, LCPG0767, FRB3270L4P, LCPG0985, FRB32806GD, FRB32806Y, LCPG1003, LCPG0783, CZC5252BGV, US04552498, LCPF0168, LCPF0168, FRB3270L12, LCPG0843, FRB3280732, LCPG0892, US04552474, US10570127, CZC52316, CZC5231GH5, LCPF0171, LCPF0130, CZC5251G1H, LCPG1253, LCPG0307, US94800162, LCPD0023, US03570619, LCPF0159, LCPG0786, US03910949, US13809040, LCPF0176, FRB3270KZL, LCPG0770, FRB328072F, LCPG0936, 2AKN9ZG01T, LCPG0440, US04552496, LCPF0169, MXL5040CBX, LCPG0680, MXL4390NHC, US14110747, LCPG0424, LCPG1113, LCPG0721, 2UA4020L7C, LCPG0540, US12754765, CZC5252BH3, 2UB3370C5S, LCPG0556, 2UB42002SF, LCPG0813, LCPG1312, 51KN9ZE925, 51KN9ZE971, LCPG0460, LCPG0467, 2UB33709QM, CZC5251GBX, LCPG0729, CZC5251H5V, SCZC52529X7, LCPG0302, CZC5231G6P, LCPG0616, LCPG1076, USC3260255, LCPG0616, LCPG1025, FRB328070R, LCPG0887, 2UA4020480, 2AKN9ZG011, 2AKN9ZG01E, LCPG0438, US14110776, US14111133, CZC52403G3, FRB3270L1Z, FRB328070H, LCPG0283, LCPG0300, 2UA4330426, MXL4360D0S, LCPG0793, 2UA4110GFC, 2UA4110GFB, LCPG0814, LCPG0299, US14110937, LCPG0420, US13804192, US14110820, LCPG1285, US14110820, USW3190C0R, LCPG0615, 2UA4020LMD, FRB3270LRT, LCPG0722, LCPG0975, US11303388, US11303620, US14014730, LCPG0251, LCPG0254, LCPG0423, 29KN9ZP1BP, LCPG0493, US14110994, SCZC5252B61, 28KN9Z70EX, LCPG0397, LCPG0383, US14110995, LCPG0232, USU32703VY, LCPG0571, US13804183, LCPG0295, 2UB3370C67, 2UB3370CR0, LCPG0677, LCPG0688, CZC52402Q4, LCPG1171, US14110928, LCPG0416, 2UA402048M, LCPG0715, US14014714, LCPG0241, US14014501, LCPG0243, 29KN9ZP1E8, LCPG0446, SCZC5252B4N, CZC5251GZH, FRB32806F8, LCPG0959, 29KN9ZP1TM, 2UA433044P, 2UB3370C5B, LCPG0495, LCPG0555, LCPG0787, US14111137, LCPG1310, LCPG0412, CZC5252BDW, LCPG0763, 2UA4220137, LCPG0763, 28KN9ZP0RJ, USU32703YD, LCPG0388, LCPG0665, LCPG1313, 2UA4020LB0, LCPG0705, USC2340J87, 29KN9ZP24L, CZC5252BHF, LCPG1107, CZC52402QY, LCPG0445, US03910979, LCPF0177, US14110854, LCPG0308, US11302407, LCPG0253, US13804157, CZC524030N, LCPG0301, 2UB33803QK, LCPG0437, FRB3270L1Q, LCPG0933, FRB3280727, LCPG1043, CZC524030P, CZC5240311, LCPG1174, LCPG1175, CZC52402QM, LCPG1244, LCPG1286, USW3190C09, LCPG0612, 2UB3370C6S, LCPG0558, MXL51603JZ, LCPG0962, FRB3270L08, LCPG0878, 2UB33706CW, LCPG0653, 2UB3370CR1, LCPG0687, 2UB3370C33, LCPG0543, 2UB3370CQ1, LCPG0685, MXL4360D1R, CZC2403GK, LCPG1026, LCPG0820, CZC524035C, FRB3280720, LCPG1110, SCZC52529Y6, SCZC5252B3T, LCPG0889, LCPG1319, LCPG1320, 29KN9ZP1ED, LCPG0533, US10570124, LCPF0129, 2UA431043K, LCPG0818, FRB3270L3X, LCPG0984, CZC52402PT, LCPG1164, FRB3270LL9, LCPG0951, MXL4390NHR, LCPG0771, MXL5040CC0, LCPG0968, FRB3270HKQ, LCPG0953, MXL4360D1L, LCPG0827, 2UA422011R, 2UA422088D, 2UA423087T, MXL4360D1Z, CZC5252BKP, CZC5252BL5, LCPD0019, LCPG0678, LCPG0802, LCPG0678, LCPG0802, LCPG0804, LCPG0678, LCPG0802, LCPG0804, CZC52403GP, LCPG1034, FRB32806DV, LCPG0989, US03570598, LCPF0158, CZC52403G2, LCPG1051, CZC5231FX1, CZC5252B9K, LCPG1061, 28KN9Z70SB, CZC5252BLC, LCPG1092, CZC524032R, LCPG1109, 2CKN9ZM19L, LCPG0534, CZC5252B7T, LCPG1166, USC3260246, LCPG0614, LCPG0553, CZC5252BBP, LCPG0405, FRB328072L, LCPG0681, 28KN9ZP1F5, LCPG0385, MXL5100795, CZC5251G63, LCPG1205, US14110830, FRB3270HJK, FRB3270LQ3, LCPG0417, 70018261, LCPG1228, 2UA433040P, LCPG0795, 28KN9ZL17N, LCPG0410, 2UA433032P, LCPG0764, CZC5231GHO, LCPG1073, CZC5252BJ3, LCPG0401, US13809118, LCPG0311, US04552493, LCPF0180, US94362911, LCPD0022, FRB32806F9, LCPG1000, USU32703XC, CZC52403GL, SU94362917, US03908709, LCPF0157, CZC524031G, US14110926, LCPG0415, LCPG1311, 51KN9ZE953, LCPG0456, CZC5251GW5, LCPG1046, 2UA4020LBG, LCPG0565, CZC5231FWZ, LCPG1056, 2AKN9ZG00B, LCPG0381, LCPG0381, 2UA4020LB3, CZC52402XX, LCPG1165, 2AKN9ZG00V, LCPG0434, SCZC5252B4G, 29KN9ZP1V5, LCPG0494, FRB32806FH, LCPG-0990, US03570644, LCPF0138, US14111089, US14111116, LCPG0309, CZC5251G2B, LCPG1072, FRB3270L84, LCPG0960, 2UA4110GFR, LCPG0784, LCPG1273, CZC524030F, PULLED, US14110814, LCPG0321, US14111141, LCPG0404, CZC525BQ5, 2AKN9ZF29B, LCPG0382, 2UA412034M, LCPG0785, LCPG0785, SCZC5252BD4, 2UA43104, LCPG0765, CZC5251GPH, LCPG1054, US14110879, LCPG00428, 28KN9ZL0DX, 28KN9ZL01J, LCPG0406, 2UB42002RY, CZC5251GDT, CZC5251GQH, FRB3270LQV, SCZC5252BOT, LCPG0810, LCPG0974, LCPG1090, LCPG1130, 28KN9ZL0HH, 28KN9ZL164, 2CKN9ZM11V, 2CKN9ZM19H, 2CKN9ZM1LV, 2CKN9ZV1M0, 2UA422010N, 2UB42002S4, US11303368, US11856174, US13813372, US94800510, CZC5240305, CZC5251GHN, LCPD0018, LCPG0255, LCPG0290, LCPG0387, LCPG0394, LCPG0403, LCPG0529, LCPG0530, LCPG0568, LCPG0569, LCPG0806, LCPG0811, LCPG0296, US13804095, US10570024, LCPF0126, 2UB42002SC, LCPG0815, LCPG0535, FRB3270KDV, LCPG0969, USW3190C0S, LCPG0623, US14111088, LCPG0298, FRB3270L6B, LCPG0986, CZC52402Y6, CZC5251GQF, LCPG0430, MXL5310FQK, CZC5252B4N, 28KN9ZN0H7, LCPG0584, 2CKN9ZV1M7, 2CKN9ZV1M7, LCPG0575, LCPG0575, LCPG0808, LCPG0828, 28KN9ZL027, LCPG0408, 2UA4330438, LCPG0766, CZC5252BHQ, LCPG1098, CZC5252BF7, LCPG1275, LCPG0491, 2UA42200Z1, LCPG0496, 28KN9ZL0PZ, 2UA41106JL, US94800373, CZC5231FWQ, CZC5251H0Z, CZC5252BJP, FRB3270LRH, FRB32806FY, 90314720(LCPG0310), LCP-E0042, LCPG-0297, LCPG0250, LCPG0384, LCPG0392, LCPG0405, LCPG0414, LCPG0422, LCPG0531, LCPG0564, LCPG1163 and LCPG1213.
Units Affected
422