Devices

Device Recall MagNA Pure LightCycler

  • Modèle / numéro de série
    Series 2.0 software version 1.1.23 and 1.1.24, Part number 05197686001, Ser Numbers LC2C00000383, LC2C00000566, LC2C00000572, LC2C00000428, LC2C00000482, LC2C00000266, LC2C00000192, LC2C00000216, LC2C00000233, LC2C00000419, LC2C00000531, LC2C00000033, LC2C00000583, LC2C00000127, LC2C00000170, LC2C00000563, LC2C00000234, LC2C00000561, LC2C00000205, LC2C00000394, LC2C00000329, LC2C00000418, LC2C00000420, LC2C00000569, LC2C00000570, LC2C00000564, LC2C00000486, LC2C00000483, LC2C00000158, LC2C00000214, LC2C00000215, LC2C00000265, LC2C00000309, LC2C00000217, LC2C00000254, LC2C00000081, LC2C00000159, LC2C00000212, LC2C00000213, LC2C00000293, LC2C00000427, LC2C00000232, LC2C00000242, LC2C00000134, LC2C00000168, LC2C00000219, LC2C00000479, LC2C00000228, LC2C00000580, LC2C00000243, LC2C00000263, LC2C00000393, LC2C00000155, LC2C00000203, LC2C00000204, LC2C00000267, LC2C00000268, LC2C00000193, LC2C00000206, LC2C00000381, LC2C00000381, LC2C00000429, LC2C00000588, LC2C00000449, LC2C00000218, LC2C00000253, LC2C00000110, LC2C00000156, LC2C00000128, LC2C00000162, LC2C00000178, LC2C00000118, LC2C00000079, LC2C00000273, LC2C00000431, LC2C00000477, LC2C00000196, LC2C00000130, LC2C00000310, LC2C00000264, LC2C00000414, LC2C00000276, LC2C00000312, LC2C00000313, LC2C00000361, LC2C00000363, LC2C00000331, LC2C00000330, LC2C00000236, LC2C00000360, LC2C00000294, LC2C00000298, LC2C00000532, LC2C00000220, LC2C00000270, LC2C00000413, LC2C00000120, LC2C00000274, LC2C00000227, LC2C00000384, LC2C00000275, LC2C00000364, LC2C00000269, LC2C00000252, LC2C00000119, LC2C00000250, LC2C00000235, LC2C00000169, LC2C00000244, LC2C00000108, LC2C00000256, LC2C00000272, LC2C00000173, LC2C00000582, LC2C00000064, LC2C00000255, LC2C00000179, LC2C00000562, LC2C00000581, LC2C00000035, LC2C00000080, LC2C00000172, LC2C00000412, LC2C00000032, LC2C00000131, LC2C00000195, LC2B00000042, LC2C00000039, LC2C00000043, LC2C00000034, LC2C00000132, LC2C00000133, LC2C00000060, LC2C00000180, LC2C00000578, LC2C00000314, LC2C00000571, 2C00000565, LC2C00000415, LC2C00000430, LC00000529, LC2C00000044, LC2C00000129, LC2C00000297, LC2C00000358, LC2C00000359, LC2C00000392 and LC2C00000434.
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution; including the islands of Puerto Rico and Hawaii.
  • Description du dispositif
    MagNA Pure LC 2.0 (software version 1.1.23 and 1.1.24) || 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 Capillaries, 96-well PCR plates, PCR tube strips) with PCR reaction mixes and template nucleic acid, or other reaction tubes for the making of dilution series, reaction mixes.
  • Manufacturer
    Roche Diagnostics Operations, Inc.
  • 1 Event

Fabricant

Roche Diagnostics Operations, Inc.
  • Adresse du fabricant
    Roche Diagnostics Operations, Inc., 9115 Hague Road, Indianapolis IN 46256-1025
  • Société-mère du fabricant (2017)
    Roche Holding AG
  • Source
    USFDA

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Device Recall MagNA Pure LightCycler
  • Modèle / numéro de série
    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.
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution; including the islands of Puerto Rico and Hawaii.
  • Description du dispositif
    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 Capillaries, 96-well PCR plates, PCR tube strips) with PCR reaction mixes and template nucleic acid, or other reaction tubes for the making of dilution series, reaction mixes.
  • Manufacturer
    Roche Diagnostics Operations, Inc.