Atellica CH 930 Analyzer (2019-09 | 合法醫療器材資訊網
2019年10月11日—Thefollowingassaysareaffected:acetaminophen(ACET),cholesterol(CHOL_2),glucoseoxidase(GLUO),triglycerides(TRIG),uricacid(UA), ...
Last updated: 2019-10-11
Affected ProductsAtellica CH 930 Analyzer
ReasonSiemens Healthcare Diagnostics, INC. has confirmed that on the Atellica CH 930 Analyzer, when a reagent lot calibration and a pack calibration (C0 adjust) on the same assay are manually ordered at the same time, the reagent lot calibration recovery of the analyte is 5 times higher because the 5x predilution factor is improperly factored into the QC and patient sample result calculation. The following assays are affected: acetaminophen (ACET), cholesterol (CHOL_2), glucose oxidase (GLUO), triglycerides (TRIG), uric acid (UA), urea nitrogen (UN_C) and inorganic phosphorus (IP). If QC is ordered with calibration and C0 adjust, QC results will be out of range high (red status on the atellica solution - calibration results details screen) and the calibration will display a status of "Awaiting Acceptanc...
Atellica CH ACET | 合法醫療器材資訊網
Acetaminophen (Acet) Atellica CH | 合法醫療器材資訊網
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Atellica CH 930 Analyzer (2019-09 | 合法醫療器材資訊網
70th AACC Annual Scientific Meeting | 合法醫療器材資訊網
【“西門子” 乙醯胺酚檢驗試劑】許可證字號:衛部醫器輸字第032175號
器材品名:“西門子”乙醯胺酚檢驗試劑許可證字號:衛部醫器輸字第032175號註銷狀態:註銷日期:註銷理由:有效日期:2024/02/15發證...