MAUDE Adverse Event Report | 合法醫療器材資訊網
Thelmmbflexreagentcartridgeinstructionsforuselimitationsofproceduresection...DIMENSION®LMMBMASSCREATINEKINASEMBISOENZYMEFLEX® ...
Analysis of the instrument and instrument data indicates that the cause for the discordant elevated lmmb result is unknown.However, the siemens headquarters support center evaluated the information made available.The determination was that the elevated mmb value is patient specific, repeatable, and discordant with the cki value.Testing on an alternate instrument system recovers a value within the normal range, congruent with the cki value.This data is consistent with non-specific binding interference.The lmmb flex reagent cartridge instructions for use limitations of procedure section states: "patient samples may contain heterophilic antibodies that could react in immunoassays to give falsely elevated or depressed results.This assay has been designed to minimize interference from heterophilic antibodi...
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MAUDE Adverse Event Report | 合法醫療器材資訊網
"德曼遜" 肌酸激(酉每)弗列克斯試劑組"Dimension" CKI Creatine ... | 合法醫療器材資訊網
Dimension® Flex® reagent cartridge ... | 合法醫療器材資訊網
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Dimension Vista® Flex® reagent cartridge CKI | 合法醫療器材資訊網
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【"德曼遜" 肌酸激(酉每)弗列克斯 試劑組】許可證字號:衛署醫器輸字第020767號
器材品名:"德曼遜"肌酸激(酉每)弗列克斯試劑組許可證字號:衛署醫器輸字第020767號註銷狀態:註銷日期:註銷理由:有效日期:20...