令和 5年 6月30日作成

一般的名称： パック式臨床化学分析装置
販売名　　： アフィニオン 2

数量：1,264台

対象シリアル：
AF20004009, AF20004048, AF20004055, AF20004173, AF20004238, AF20004316,
AF20004346, AF20004369, AF20004370, AF20004442, AF20004613, AF20004660,
AF20004670, AF20004683, AF20004737, AF20004740, AF20004772, AF20004781,
AF20004791, AF20004807, AF20004915, AF20004917, AF20004926, AF20005159,
AF20005209, AF20005240, AF20005279, AF20005403, AF20005747, AF20005856,
AF20005970, AF20006041, AF20006071, AF20006100, AF20006134, AF20006168,
AF20006325, AF20006336, AF20006360, AF20006421, AF20006479, AF20006669,
AF20006689, AF20006728, AF20006962, AF20006984, AF20007115, AF20007203,
AF20007222, AF20007302, AF20007328, AF20007340, AF20007359, AF20007382,
AF20007392, AF20007397, AF20007405, AF20007410, AF20007420, AF20007432,
AF20007486, AF20007496, AF20007497, AF20007684, AF20007998, AF20008092,
AF20008467, AF20008545, AF20008569, AF20008690, AF20008772, AF20008950,
AF20009040, AF20009296, AF20009481, AF20009656, AF20009662, AF20009682,
AF20009686, AF20009687, AF20009691, AF20009739, AF20009743, AF20009780,
AF20009837, AF20009857, AF20009858, AF20009870, AF20009872, AF20009919,
AF20009941, AF20009983, AF20010019, AF20010175, AF20010202, AF20010376,
AF20010533, AF20010547, AF20010567, AF20010588, AF20010710, AF20010755,
AF20010766, AF20010777, AF20010811, AF20010843, AF20010976, AF20010978,
AF20010987, AF20011052, AF20011092, AF20011113, AF20011157, AF20011185,
AF20011219, AF20011219, AF20011228, AF20011228, AF20011233, AF20011234,
AF20011235, AF20011247, AF20011251, AF20011265, AF20011357, AF20011358,
AF20011409, AF20011452, AF20011974, AF20012085, AF20012094, AF20012143,
AF20012162, AF20012436, AF20012437, AF20012490, AF20012505, AF20012592,
AF20012604, AF20012605, AF20012617, AF20012618, AF20012628, AF20012640,
AF20012660, AF20012719, AF20012739, AF20012786, AF20012793, AF20012826,
AF20012830, AF20012840, AF20015258, AF20015265, AF20015276, AF20015280,
AF20015404, AF20015487, AF20015540, AF20015551, AF20015573, AF20015642,
AF20015817, AF20015822, AF20015866, AF20015868, AF20016020, AF20016030,
AF20016035, AF20016083, AF20016140, AF20016374, AF20016400, AF20016545,
AF20016566, AF20016601, AF20016617, AF20016631, AF20016653, AF20016660,
AF20016666, AF20016670, AF20016688, AF20016703, AF20016741, AF20016749,
AF20016750, AF20016754, AF20016755, AF20016780, AF20016799, AF20016809,
AF20016818, AF20016821, AF20016864, AF20016889, AF20016907, AF20016927,
AF20017322, AF20017376, AF20017421, AF20017423, AF20017489, AF20017492,
AF20017495, AF20017498, AF20017499, AF20017553, AF20017728, AF20017729,
AF20017730, AF20017752, AF20017754, AF20017761, AF20017785, AF20017787,
AF20017793, AF20017816, AF20017819, AF20017821, AF20017975, AF20018086,
AF20018104, AF20018343, AF20018466, AF20018607, AF20018709, AF20018766,
AF20018767, AF20018789, AF20018835, AF20018875, AF20018885, AF20018886,
AF20018887, AF20018925, AF20018929, AF20018962, AF20019010, AF20019076,
AF20019104, AF20019241, AF20019269, AF20019307, AF20019342, AF20019389,
AF20019413, AF20019494, AF20019547, AF20019562, AF20019608, AF20019748,
AF20019758, AF20019780, AF20019855, AF20019860, AF20019964, AF20020070,
AF20020256, AF20020278, AF20020301, AF20020310, AF20020312, AF20020313,
AF20020317, AF20020345, AF20020353, AF20020419, AF20020435, AF20020439,
AF20020569, AF20020581, AF20020621, AF20020662, AF20020675, AF20020747,
AF20020926, AF20020946, AF20021072, AF20021191, AF20021269, AF20021351,
AF20021376, AF20021438, AF20021447, AF20021470, AF20021649, AF20021820,
AF20021820, AF20021838, AF20021908, AF20021946, AF20021959, AF20022042,
AF20022136, AF20022142, AF20022244, AF20022268, AF20022310, AF20022319,
AF20022337, AF20022343, AF20022378, AF20022394, AF20022466, AF20022534,
AF20022617, AF20022634, AF20022670, AF20022696, AF20022724, AF20022784,
AF20022909, AF20022932, AF20022938, AF20022943, AF20022977, AF20022993,
AF20023013, AF20023014, AF20023025, AF20023026, AF20023028, AF20023038,
AF20023052, AF20023100, AF20023112, AF20023216, AF20023229, AF20023240,
AF20023243, AF20023393, AF20023430, AF20023510, AF20023514, AF20023695,
AF20023736, AF20023738, AF20023847, AF20024271, AF20024273, AF20024357,
AF20024612, AF20024620, AF20024740, AF20024755, AF20024785, AF20024803,
AF20024838, AF20024853, AF20024855, AF20024875, AF20024899, AF20024931,
AF20024938, AF20024953, AF20024970, AF20025000, AF20025043, AF20025100,
AF20025106, AF20025117, AF20025161, AF20025162, AF20025196, AF20025213,
AF20025227, AF20025230, AF20025240, AF20025255, AF20025278, AF20025283,
AF20025286, AF20025294, AF20025296, AF20025303, AF20025325, AF20025326,
AF20025329, AF20025376, AF20025392, AF20025398, AF20025427, AF20025439,
AF20025449, AF20025458, AF20025480, AF20025506, AF20025512, AF20025529,
AF20025579, AF20025583, AF20025595, AF20025604, AF20025606, AF20025608,
AF20025609, AF20025626, AF20025629, AF20025632, AF20025634, AF20025641,
AF20025672, AF20025738, AF20025773, AF20025777, AF20025836, AF20025841,
AF20025863, AF20025863, AF20025932, AF20025983, AF20025999, AF20026196,
AF20026205, AF20026234, AF20026270, AF20026318, AF20026323, AF20026367,
AF20026417, AF20026449, AF20026497, AF20026509, AF20026545, AF20026620,
AF20026626, AF20026766, AF20026841, AF20026880, AF20026962. AF20027010,
AF20027029, AF20027123, AF20027127, AF20027140, AF20027141, AF20027167,
AF20027199, AF20027202, AF20027205, AF20027215, AF20027216, AF20027259,
AF20027271, AF20027302, AF20027317, AF20027382, AF20027416, AF20027437,
AF20027505, AF20027603, AF20027664, AF20027665, AF20027688, AF20027692,
AF20027722, AF20027760, AF20027782, AF20027800, AF20027821, AF20027831,
AF20027835, AF20027840, AF20027842, AF20027852, AF20027859, AF20027863,
AF20027906, AF20027911, AF20027929, AF20027932, AF20027951, AF20027976,
AF20028002, AF20028010, AF20028034, AF20028055, AF20028081, AF20028141,
AF20028148, AF20028150, AF20028228, AF20028271, AF20028285, AF20028303,
AF20028333, AF20028339, AF20028340, AF20028379, AF20028614, AF20028622,
AF20028661, AF20028675, AF20028710, AF20028788, AF20028791, AF20028792,
AF20028794, AF20028841, AF20028845, AF20028847, AF20028849, AF20028864,
AF20028867, AF20028897, AF20028900, AF20028923, AF20028935, AF20028989,
AF20029008, AF20029030, AF20029040, AF20029078, AF20029090, AF20029106,
AF20029138, AF20029182, AF20029189, AF20029201, AF20029220, AF20029221,
AF20029230, AF20029239, AF20029259, AF20029277, AF20029286, AF20029294,
AF20029295, AF20029311, AF20029314, AF20029316, AF20029322, AF20029330,
AF20029347, AF20029369, AF20029424, AF20029433, AF20029458, AF20029470,
AF20029475, AF20029477, AF20029479, AF20029489, AF20029493, AF20029497,
AF20029524, AF20029547, AF20029558, AF20029579, AF20029580, AF20029581,
AF20029585, AF20029595, AF20029597, AF20029598, AF20029606, AF20029618,
AF20029624, AF20029629, AF20029631, AF20029637, AF20029640, AF20029829,
AF20029932, AF20032026, AF20032134, AF20032275, AF20032335, AF20032342,
AF20032369, AF20032371, AF20032406, AF20032570, AF20032635, AF20032670,
AF20032711, AF20032758, AF20032791, AF20032815, AF20032935, AF20032964,
AF20032995, AF20033000, AF20033006, AF20033034, AF20033035, AF20033038,
AF20033358, AF20033359, AF20034009, AF20034014, AF20034048, AF20034148,
AF20034258, AF20034324, AF20034423, AF20034452, AF20034470, AF20034536,
AF20034546, AF20034849, AF20034851, AF20034890, AF20034952, AF20035072,
AF20035145, AF20035168, AF20035175, AF20035206, AF20035261, AF20035262,
AF20035308, AF20035316, AF20035348, AF20035362, AF20035370, AF20035379,
AF20035397, AF20035399, AF20035401, AF20035411, AF20035415, AF20035417,
AF20035424, AF20035425, AF20035443, AF20035451, AF20035454, AF20035463,
AF20035471, AF20035477, AF20035486, AF20035491, AF20035498, AF20035535,
AF20035539, AF20035546, AF20035563, AF20035581, AF20035591, AF20035592,
AF20035614, AF20035621, AF20035628, AF20035705, AF20035708, AF20035731,
AF20035744, AF20035766, AF20035804, AF20035810, AF20035832, AF20035845,
AF20035848, AF20035884, AF20035900, AF20035991, AF20036034, AF20036053,
AF20036080, AF20036082, AF20036085, AF20036094, AF20036132, AF20036213,
AF20036282, AF20036292, AF20036293, AF20036300, AF20036307, AF20036322,
AF20036330, AF20036348, AF20036355, AF20036370, AF20036396, AF20036398,
AF20036423, AF20036437, AF20036456, AF20036465, AF20036919, AF20037029,
AF20037032, AF20037042, AF20037044, AF20037068, AF20037071, AF20037102,
AF20037119, AF20037168, AF20037184, AF20037193, AF20037208, AF20037212,
AF20037214, AF20037215, AF20037221, AF20037234, AF20037242, AF20037254,
AF20037256, AF20037257, AF20037277, AF20037337, AF20037343, AF20037435,
AF20037503, AF20037653, AF20037667, AF20037740, AF20037765, AF20037875,
AF20037881, AF20037917, AF20037977, AF20037978, AF20037981, AF20037991,
AF20038059, AF20038064, AF20038088, AF20038110, AF20038115, AF20038149,
AF20038157, AF20038162, AF20038196, AF20038210, AF20038249, AF20038269,
AF20038279, AF20038284, AF20038286, AF20038300, AF20038312, AF20038313,
AF20038366, AF20038379, AF20038385, AF20038393, AF20038440, AF20038443,
AF20038456, AF20038459, AF20038465, AF20038511, AF20038517, AF20038523,
AF20038527, AF20038537, AF20038541, AF20038547, AF20038571, AF20038575,
AF20038582, AF20038587, AF20038592, AF20038598, AF20038610, AF20038612,
AF20038623, AF20038624, AF20038625, AF20038638, AF20038640, AF20038642,
AF20038644, AF20038647, AF20038675, AF20038679, AF20038685, AF20038911,
AF20039129, AF20039309, AF20039697, AF20039729, AF20039764, AF20040061,
AF20040228, AF20040271, AF20040321, AF20040346, AF20040399, AF20040435,
AF20040456, AF20040529, AF20040539, AF20040543, AF20040574, AF20040582,
AF20040583, AF20040584, AF20040589, AF20040593, AF20040600, AF20040601,
AF20040603, AF20040612, AF20040613, AF20040616, AF20040630, AF20040637,
AF20040640, AF20040644, AF20040649, AF20040650, AF20040651, AF20040655,
AF20040661, AF20040664, AF20040671, AF20040676, AF20040683, AF20040687,
AF20040691, AF20040697, AF20040703, AF20040707, AF20040710, AF20040712,
AF20040715, AF20040719, AF20040724, AF20040725, AF20040728, AF20040730,
AF20040735, AF20040737, AF20040739, AF20040740, AF20040743, AF20040745,
AF20040746, AF20040749, AF20040757, AF20040758, AF20040765, AF20040768,
AF20040773, AF20040784, AF20040814, AF20040842, AF20040876, AF20040885,
AF20040890, AF20041070, AF20041365, AF20042238, AF20042287, AF20042315,
AF20042827, AF20042927, AF20042946, AF20042954, AF20042978, AF20042989,
AF20043189, AF20043358, AF20043483, AF20043609, AF20043620, AF20043621,
AF20043633, AF20043774, AF20043787, AF20043803, AF20044177, AF20044218,
AF20044234, AF20044271, AF20044405, AF20044542, AF20044597, AF20044630,
AF20044669, AF20044706, AF20044759, AF20044766, AF20044800, AF20044803,
AF20044826, AF20044841, AF20044872, AF20044961, AF20045034, AF20045058,
AF20045082, AF20045108, AF20045110, AF20045113, AF20045114, AF20045131,
AF20045144, AF20045147, AF20045153, AF20045155, AF20045159, AF20045166,
AF20045198, AF20045209, AF20045211, AF20045219, AF20045257, AF20045258,
AF20045265, AF20045275, AF20045317, AF20045331, AF20045410, AF20045452,
AF20045496, AF20045572, AF20045649, AF20045783, AF20045859, AF20045937,
AF20045946, AF20045969, AF20046044, AF20046055, AF20046057, AF20046060,
AF20046072, AF20046085, AF20046091, AF20046097, AF20046119, AF20046123,
AF20046124, AF20046146, AF20046151, AF20046162, AF20046165, AF20046173,
AF20046178, AF20046201, AF20046214, AF20046226, AF20046251, AF20046252,
AF20046260, AF20046279, AF20046314, AF20046339, AF20046383, AF20046396,
AF20046399, AF20046406, AF20046555, AF20046568, AF20046736, AF20046771,
AF20046840, AF20046861, AF20047037, AF20047062, AF20047074, AF20047082,
AF20047120, AF20047141, AF20047144, AF20047193, AF20047199, AF20047327,
AF20047361, AF20047431, AF20047481, AF20047509, AF20047522, AF20047577,
AF20047624, AF20047631, AF20047659, AF20047679, AF20047747, AF20047759,
AF20047829, AF20047835, AF20047837, AF20047852, AF20047855, AF20047859,
AF20047868, AF20047874, AF20047905, AF20048012, AF20048027, AF20048039,
AF20048114, AF20048196, AF20048264, AF20048339, AF20048346, AF20048354,
AF20048388, AF20048389, AF20048397, AF20048413, AF20048415, AF20048440,
AF20048468, AF20048499, AF20048534, AF20048603, AF20048622, AF20048627,
AF20048643, AF20048652, AF20048661, AF20048664, AF20048669, AF20048677,
AF20048678, AF20048682, AF20048686, AF20048793, AF20048821, AF20048824,
AF20049011, AF20049022, AF20049060, AF20049061, AF20049067, AF20049075,
AF20049093, AF20049142, AF20049145, AF20049165, AF20049171, AF20049173,
AF20049174, AF20049180, AF20049204, AF20049220, AF20049259, AF20049288,
AF20049318, AF20049541, AF20049581, AF20049780, AF20049839, AF20049844,
AF20049857, AF20049866, AF20049869, AF20049877, AF20049880, AF20049888,
AF20049908, AF20049937, AF20050081, AF20050093, AF20050203, AF20050247,
AF20050318, AF20050325, AF20050326, AF20050332, AF20050349, AF20050353,
AF20050354, AF20050367, AF20050389, AF20050402, AF20050418, AF20050419,
AF20050420, AF20050438, AF20050473, AF20050476, AF20050588, AF20050604,
AF20050702, AF20050774, AF20050822, AF20050825, AF20050843, AF20050863,
AF20050871, AF20050877, AF20050878, AF20050895, AF20050896, AF20050902,
AF20050903, AF20050943, AF20050957, AF20050966, AF20050969, AF20051004,
AF20051006, AF20051014, AF20051027, AF20051068, AF20051084, AF20051085,
AF20051103, AF20051126, AF20051136, AF20051143, AF20051303, AF20051404,
AF20051482, AF20051775, AF20051797, AF20051846, AF20051855, AF20051903,
AF20051959, AF20051973, AF20052074, AF20052227, AF20052446, AF20052612,
AF20052676, AF20052678, AF20052686, AF20052696, AF20052699, AF20052700,
AF20052701, AF20052704, AF20052705, AF20052722, AF20052728, AF20052735,
AF20052741, AF20052746, AF20052748, AF20052756, AF20052758, AF20052764,
AF20052770, AF20052773, AF20052776, AF20052778, AF20052802, AF20052803,
AF20052807, AF20052811, AF20052813, AF20052823, AF20052829, AF20052896,
AF20052974, AF20052997, AF20053008, AF20053009, AF20053038, AF20053066,
AF20053072, AF20053136, AF20053156, AF20053294, AF20053325, AF20053326,
AF20053332, AF20053343, AF20053344, AF20053345, AF20053349, AF20053351,
AF20053353, AF20053355, AF20053364, AF20053365, AF20053375, AF20053387,
AF20053388, AF20053412, AF20053418, AF20053607, AF20053609, AF20053617,
AF20053621, AF20053626, AF20053628, AF20053630, AF20053631, AF20053638,
AF20053652, AF20053660, AF20053669, AF20053678, AF20053679, AF20053690,
AF20053692, AF20053694, AF20053700, AF20053701, AF20053706, AF20053720,
AF20053726, AF20053730, AF20053738, AF20053793, AF20053797, AF20054057,
AF20054058, AF20054105, AF20054127, AF20054136, AF20054160, AF20054171,
AF20054175, AF20054186, AF20054190, AF20054191, AF20054214, AF20054219,
AF20054230, AF20054241, AF20054246, AF20054250, AF20054253, AF20054272,
AF20054276, AF20054283, AF20054286, AF20054290, AF20054294, AF20054299,
AF20054356, AF20054366, AF20054373, AF20054374, AF20054551, AF20054719,
AF20054735, AF20054737, AF20054743, AF20054837, AF20054866, AF20054875,
AF20054965, AF20055016, AF20055041, AF20055047, AF20055058, AF20055066,
AF20055105, AF20055113, AF20055124, AF20055125, AF20055132, AF20055134,
AF20055135, AF20055306, AF20055352, AF20055382, AF20055685, AF20055726,
AF20055852, AF20056403, AF20057548, AF20057711, AF20058064, AF20058130,
AF20058196, AF20058218, AF20058443, AF20074407


出荷時期：2018年7月25日〜2023年4月28日

製造販売業者の名称　： アボット　ダイアグノスティクス　メディカル株式会社
製造販売業者の所在地： 千葉県松戸市松飛台357
許可の種類　　　　　： 第一種医療機器製造販売業
許可番号　　　　　　： 12B1X10004
輸入先製造業者名：Abbott Diagnostics Technologies AS（ノルウェー）

海外製造元により、ソフトウェアバージョンが21.13以前のアフィニオン 2において過熱に関連する問題が発生
する可能性が確認されました。この問題はソフトウェアの不具合により、カートリッジチャンバーのカバーを制
御するモーターが一定時間経過後も稼働状態のままになる場合に発生します。
また、ソフトウェアバージョン21.05、21.06、21.07、21.08のアフィニオン 2において、接続設定を「Patient
Results Only」に設定し、コントロールサンプルを測定した場合、測定データの送信の停止や何も値が入ってい
ないデータが送信され続けるため、ネットワーク上の送信トラブルを引き起こす可能性が確認されました。この
問題はASTM-LL、ASTM-HL及びHL7通信プロトコルに影響し、POCT1-A通信プロトコルには影響しません。
これらの問題を修正するため、ソフトウェアをバージョン21.14に更新する改修を決定しました。

過熱に関する不具合が発生した場合、モーターの過負荷によりカートリッジチャンバーのカバーが熱を帯び変形
し測定不能になる恐れがありますが、火傷するような温度には達しないことが確認されています。また、コント
ロール測定時の送信不具合は、コントロールの測定時にのみ発生し、患者の検査結果には影響しません。よっ
て、重篤な健康被害の発生の可能性はないと考えます。
なお、現在までに本事象による健康被害発生の報告は受けておりません。

令和5年6月30日

化学物質又はヒト組織試料の定性・定量分析に用いる自動又は半自動の装置をいい、袋などの容器に用意された
試薬と結合した試料を光度分析することにより機能する。本装置はグラフィック及びデータ出力の機能も備えて
いる。

当該医療機器の納入先は全て把握しておりますので、文書で情報提供すると共に適切に改修を実施いたします。

担当者　： アボット　ダイアグノスティクス　メディカル株式会社　お客様相談室
連絡先　： 東京都新宿区西新宿2-4-1 新宿NSビル7階
電話番号： 0120-1874-86
　　　　　 （受付時間：9:00〜17:00 土日、祝日を除く）