MAUDE Adverse Event Report | 合法醫療器材資訊網
Investigationdeterminedthatdimensionsiroloteb6064doesnotmeettheopen...BrandName,DIMENSION®SIROLIMUSFLEX®REAGENTCARTRIDGE.
Siemens healthcare diagnostics received customer complaints for dimension sirolimus (siro) lot eb6064.The complaints were related to qc shifts and imprecision.Siemens healthcare diagnostics conducted an investigation on board stability for dimension siro lot eb6064.Investigation determined that dimension siro lot eb6064 does not meet the open well stability claim of two days.Internal testing has shown biases ranging from -82% to +123% on a pooled sample with a sirolimus concentration o 8.7 ng/ml [9.5 mmol/l] when tested on subsequent days of the two day open well stability period.Results are unaffected at the start of the open well stability period.Quality control is likely to catch the issue on subsequent days of the open well stability claim.Siemens healthcare diagnostics issued an urgent medical de...
510(k) Premarket Notification | 合法醫療器材資訊網
Class 2 Device Recall Dimension Sirolimus (SIRO) Flex | 合法醫療器材資訊網
Class 2 Device Recall Dimension Sirolimus (SIRO) Flex ... | 合法醫療器材資訊網
Dimension Siro Flex Reagent Cartridge And Dimension Sirolimus ... | 合法醫療器材資訊網
Dimension SIRO Reagent Cartridge | 合法醫療器材資訊網
International Medical Devices Database | 合法醫療器材資訊網
MAUDE Adverse Event Report | 合法醫療器材資訊網
MAUDE Adverse Event Report | 合法醫療器材資訊網
【"德曼遜" 西羅莫司 弗列克斯 試劑組】許可證字號:衛署醫器輸字第020826號
器材品名:"德曼遜"西羅莫司弗列克斯試劑組許可證字號:衛署醫器輸字第020826號註銷狀態:註銷日期:註銷理由:有效日期:2025/02/...