令和3年1月15日作成

一般的名称：乾式臨床化学分析装置
販売名　　：スポットケム Dコンセプト

商品コード：17401
商品名：スポットケム Dコンセプト　操作ユニット (スポットケム D-00）
製造番号：

10507035,10507039,10703001,10703002,10703003,10703004,10704001,10704002,10704004,10704005,
10704006,10704008,10704009,10704010,10704011,10704012,10704013,10704014,10704015,10704016,
10704017,10704020,10704021,10704022,10704024,10704025,10704026,10704027,10704028,10704029,
10705001,10705003,10705004,10705005,10705006,10705009,10705010,10705011,10705012,10705013,
10705016,10705017,10705019,10705020,10705022,10705023,10705024,10705025,10705026,10705027,
10705028,10705030,10705031,10705032,10705033,10705034,10705035,10705036,10705037,10705038,
10705039,10705040,10705041,10705042,10705043,10705044,10705046,10705047,10705048,10705049,
10705050,10706001,10706004,10706007,10706008,10706009,10706010,10706013,10706014,10706015,
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40803054,40803056,40803057,40803058,40803059,40803060,40804001,40804002,40804003,40804004,
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40908047,40908048,40908049,40908050,40908051,40908052,40908053,40908054,40908055,40908057,
40908058,40908059,40908060,40910001,40910002,40910004,40910005,40910006,40910007,40910009,
40910010,40910013,40910014,40910015,40910017,40910018,41004009,41004010,41004013,41004015,
41004016,41004017,41004018,41004020,41004021,41004022,41004023,41004024,41004025,41004026,
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41009004,41009005,41009006,41009007,41009008,41009009,41009010,41009011,41009013,41009014,
41009015,41009016,41009017,41009018,41009019,41009020,41012007,41012008,41012014,41012015,
41012016,41012018,41012019,41012020,41012021,41012022,41012023,41012024,41012025,41102002,
41102006,41102007,41102008,41102009,41102010,41106001,41106002,41106003,41106004,41106005,
41106006,41106007,41106008,41106009,41106010,41106011,41106012,41106013,41106016,41106017,
41106018,41106019,41108002,41108004,41108005,41108009,41108010,41109002,41109003,41109004,
41109010,41109011,41109013,41109014,41109016,41109017,41109018,41109019,41109020,41110014,
41110015,41110016,41110019,41110021,41110024,41110026,41110027,41110028,41110029,41110030,
41112001,41112004,41112006,41112007,41112008,41112009,41112011,41112012,41112013,41112015,
41112017,41112019,41201011,41201013,41201014,41201015,41201016,41201018,41201020,41201021,
41201022,41201024,41201025,41207001,41207002,41207003,41207004,41207006,41207007,41207008,
41207009,41207010,41207012,41207013,41207015,41208004,41209015,41209017,41211001,41211003,
41211005,41211007,41212012,41212018,41212023,41212029,41212030,41212031,41212032,41212033,
41212034,41302015,41302016,41302019,41303001,41303002,41305001,41305002,41305003,41305012,
41305020,41305021,41305022,41305023,41307001,41307008,41307009,41307014,41307016,41308003,
41308005,41308006,41308008,41308010,41308012,41308013,41308014,41308016,41308022,41308023,
41308025,41308027,41308028,41308030,41308032,41310002,41310003,41310004,41310005,41310007,
41310023,41310027,41310028,41310029,41310032,41310033,41310034,41310038,41312006,41312008,
41312010,41312013,41312015,41312016,41312019,41312023,41312025,41312026,41312027,41312039,
41403003,41403005,41403006,41403007,41403008,41403009,41403010,41403011,41403012,41403013,
41403014,41403015,41403027,41403028,41403029,41403030,41403031,41403032,41403033,41403034,
41404001,41404002,41404003,41404005,41404021,41404022,41404023,41404024,41404025,41404027,
41404028,41405001,41405002,41405003,41405004,41405005,41405006,41405007,51407001,51407003,
51407004,51407005,51407006,51407007,51407008,51407009,51407010,51407011,51407013,51407014,
51407015,51407016,51407017,51407018,51407019,51407020,51407021,51407022,51407023,51407024,
51407025,51407026,51407027,51407028,51407030,51407031,51407032,51407033,51407034,51407035,
51407036,51407039,51407040,51407041,51407042,51407043,51407044,51407045,51407046,51407047,
51407048,51407049,51407050,51409001,51409002,51409003,51409004,51409005,51409006,51409008,
51409009,51409010,51411001,51411002,51411003,51411004,51411005,51411006,51411007,51411008,
51411009,51411010,51412002,51412004,51412005,51412006,51412009,51412010,51508001,51508002,
51508003,51508004,51508005,51508006,51508007,51508008,51508009,51508010,51508011,51508012,
51508013,51508014,51508015,51508016,51508017,51508018,51508019,51508020,51508021,51508022,
51508023,51508024,51508025,51508026,51508027,51508037,51508038,51508039,51508040,51508041,
51508042,51508043,51508044,51508045,51508046,51508047,51509002,51509003,51509005,51509016,
51509017,51509018,51509019,51509020,51511001,51511002,51511003,51511004,51511005,51511006,
51511007,51511008,51511009,51511010,51511011,51511012,51511013,51511014,51511015,51511016,
51511017,51511019,51511020,51511021,51511022,51511023,51511024,51511025,51511026,51511028,
51511029,51511030,51511031,51511042,51511043,51511044,51511045,51511046,51511047,51511048,
51511049,51511050,51511051,51511052,51511053,51511054,51511055,51511056,51511057,51511058,
51511059,51511060,51512023,51512024,51512025,51512026,51512027,51512028,51512029,51512030,
51512031,51512032,51512033,51512034,51512035,51512036,51512037,51512039,51512040,51512042,
51512043,51512044,51512045,51512046,51512047,51601016,51601017,51601018,51601019,51601020,
51601022,51601023,51601024,51601025,51602001,51602002,51602003,51602004,51602005,51602006,
51602007,51602008,51602009,51602010,51605001,51605002,51605003,51605004,51605005,51605006,
51605007,51605008,51605009,51605010,51605026,51605027,51605028,51605029,51605030,51605031,
51605032,51605033,51605034,51605035,51606001,51606002,51606003,51606004,51606005,51606006,
51606007,51606008,51606009,51606010,51607001,51607002,51607003,51607004,51607005,51607006,
51607007,51607009,51607010,51607011,51608001,51608002,51608003,51608004,51608005,51608006,
51608007,51608008,51608009,51608010,51608011,51608012,51608013,51608014,51608015,51611002,
51611003,51611004,51611005,51611006,51611007,51611008,51611009,51611010,51611011,51611012,
51611013,51611014,51611015,51611016,51611017,51611018,51611019,51611020,51611021,51611022,
51611023,51611024,51611025,51612001,51612002,51612006,51612007,51612008,51612009,51612010,
51701001,51701002,51701003,51701004,51701005,51701006,51701007,51701008,51701009,51701010,
51701011,51701012,51701013,51701014,51701015,51701016,51701017,51701018,51701019,51701020,
51701021,51702001,51702002,51702003,51702004,51702005,51702006,51702007,51702008,51702009,
51702010,51702011,51702012,51702013,51702014,51702015,51702016,51702017,51702018,51702019,
51703008,51703009,51703010,51703011,51703012,51703013,51703014,51703015,51703016,51703017,
51703018,51703019,51703020,61701001,61701002,61701003,61701004,61701005,61701006,61701007,
61703001,61703002,61703003,61703004,61703005,61703006,61703007,61703008,61703009,61703010,
61806003,61806016,61810033


数量　　：1,193台
出荷時期：平成19年3月26日〜平成30年2月7日



商品コード：104932
商品名：スポットケム Dコンセプト　操作ユニット (スポットケム D-00 QR）
製造番号：

11802001,11802002,11802003,11802004,11802005,11802006,11802007,11802008,11802009,11802010,
11802012,11802013,11802014,11802015,11802016,11802017,11802018,11802019,11802020,11802021,
11802022,11802023,11802024,11802026,11802027,11803001,11803002,11803004,11803005,11803006,
11803007,11803008,11803009,11803010,11803011,11803012,11803013,11803014,11803015,11803016,
11803017,11803018,11803019,11803020,11803021,11803022,11803023,11803024,11803025,11803026,
11803027,11803028,11803029,11803030,11803031,61806001,61806002,61806004,61806005,61806006,
61806007,61806008,61806009,61806010,61806011,61806012,61806013,61806014,61806015,61806017,
61806018,61806019,61806020,61806021,61806022,61806023,61808001,61808002,61808003,61808004,
61808005,61808006,61808007,61808008,61808009,61810001,61810002,61810003,61810004,61810005,
61810006,61810007,61810008,61810009,61810010,61810011,61810012,61810013,61810014,61810015,
61810016,61810017,61810018,61810019,61810020,61810021,61810022,61810023,61810024,61810025,
61810026,61810027,61810028,61810029,61810030,61810031,61810032,61810034,61810035,61810036,
61810037,61810038,61810039,61810040,61901001,61901002,61901003,61901004,61901005,61901006,
61901007,61901008,61901009,61901010,61901011,61901012,61901013,61901014,61901015,61901016,
61901017,61901018,61901019,61901020,61901021,61901022,61901023,61901024,61901025,61901026,
61901027,61901028,61901029,61901030,61901031,61901032,61901033,61903003,61903004,61903005,
61903006,61903007,61903008,61903009,61903010,61903011,61903012,61903013,61903014,61903015,
61903016,61903017,61903018,61903019,61903020,61903021,61903022,61903023,61903024,61903025,
61903026,61903027,61903028,61903029,61903030,61904001,61904002,61904003,61904004,61904005,
61904006,61904007,61904008,61904009,61904010,61907001,61907002,61907003,61907004,61909001,
61909002,61909003,61909004,61909005,61909006,61909007,61909008,61909009,61909010,61909011,
61909012,61909013,61909014,61909015,61909016,61909017,61909018,61909019,61909020,61909051,
61909052,61909053,61909054,61909055,61909056,61909057,61909058,61909059,61909060,61909061,
61909062,61909063,61909064,61909065,61909066,61909067,61909068,61909069,61909070,61909071,
61909072,61909073,61909074,61909075


数量　　：244台
出荷時期：平成30年2月15日〜令和2年12月2日

製造販売業者の名称　： 株式会社 アークレイ ファクトリー
製造販売業者の所在地： 滋賀県甲賀市甲南町柑子1480番地
許可の種類　　　　　： 第一種医療機器製造販売業
許可番号　　　　　　： 25B1X00001

スポットケム Dコンセプトの測定ユニット(スポットケムD-02)と専用試薬である電解質プレート(スポットケ
ムD 電解質セット(Na,K,Cl))を用いて、電解質濃度がゼロ付近の検体を検体種別設定において尿を選択し測
定（以下、尿モード測定という）した場合に、カリウム（K）及びクロール（Cl）において測定下限未満を意
味するUNDERが表示されるべきところ、UNDERが表示されずに測定結果が表示されることが判明しました。
具体的には、UNDERはKが1mmol/L未満、Clが3mmol/L未満のときに表示されますが、電解質濃度がゼロ付近の
検体として水を測定した場合に、影響が大きいとKが3mmol/L程度、Clが30mmol/L程度の測定結果を表示する
可能性があります。
なお、血液（全血・血清・血漿）を試料として測定する場合は問題が発生しません。

Kにおいては、上記の正誤差による具体的な健康被害は発生しないものと考えます。一方、Clにおいては、上
記の正誤差によって、代謝性アルカローシスの鑑別を誤り、生理食塩水の投与が遅れてアルカローシスの症
状改善が遅延する可能性を否定できません。しかし、診断については臨床症状や他の検査結果を含めて医師
が総合的に判断するため、重篤な健康被害は発生しないものと考えます。なお、現在までに健康被害の報告
はございません。

令和3年1月14日　　情報提供の開始

化学物質、ヒト組織試料、又は試薬とヒト組織との反応により生じた化学物質の定性・定量分析に用いる自動
又は半自動の装置をいう。試料を含侵した試薬浸透テストストリップ又は多層フィルムから反射される光量を
測定することにより機能する。

分析物と抗体とで反応生成された免疫複合体からの光散乱強度測定により、体液中の分析物を定量する自動ま
たは半自動の光散乱分析装置をいう。専用の試薬を用いる。本装置はレーザネフェロメータとも呼ばれる。移
動式のものをいう。

外部参照電極及び内部参照電極を含むイオン選択性電極（ISE）を用いて、電位差による種々の測定を行う自
動又は半自動の装置をいう。汎用分析装置の一部又は独立型のものがある。外部参照電極とISEは未知の試料
溶液に曝され、試料溶液の電位は外部参照電極との比較で測定する。各種のイオン選択性電極により特定の
分析のための測定ができる。

当該機器を納入した施設は全て把握しており、納入先には改修する旨を通知した上で当該製品の改修を実施し
ます。

担当者　： 佐々木　龍一
連絡先　： 株式会社 アークレイ ファクトリー
　　　　　 滋賀県甲賀市甲南町柑子1480番地
電話番号： 0748-86-6889
FAX番号 ： 0748-86-5347