VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 2 ... | 合法醫療器材資訊網
[139327218] The investigation determined that a lower than expected vitros na+ (sodium) result was obtained from a non-vitros (biorad) quality control (qc) fluid when run on a vitros 350 chemistry system. The assignable cause is related to a sub-optimal calibration due to calibrator fluids not being reconstituted correctly. Since the re-calibration using the same lot of reagent, calibrator fluids, and erf resolved the issue, a reagent issue is not likely to be a contributing factor. Although a within run precision test to verify the instrument was not completed, there is no indication of an instrument malfunction. Patient Sequence No: 1, Text Type: N, H10
[139327219] A customer obtained a lower than expected vitros...
Class 2 Device Recall VITROS Chemistry Products Calibrator ... | 合法醫療器材資訊網
VITROS Chemistry Products Calibrator Kit 2 (2019 | 合法醫療器材資訊網
VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 2 ... | 合法醫療器材資訊網
VITROS Chemistry Products Calibrator Kit 2 | 合法醫療器材資訊網
VITROS Chemistry Products Calibrator Kit 2 | 合法醫療器材資訊網
【維特司生化產品 2 號校正液】許可證字號:衛署醫器輸字第012420號
器材品名:維特司生化產品2號校正液許可證字號:衛署醫器輸字第012420號註銷狀態:註銷日期:註銷理由:有效日期:2025/09/19發證...