Device Recall Beckman Coulter HbA1c APT

  • 모델명 / 제조번호(시리얼번호)
    Lot Numbers: 9390 & 9472
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA (Nationwide) Austria, Croatia, France, Germany, Korea, Philippines, Russian Federation, Thailand, Venezuela, and Vietnam.
  • 제품 설명
    Beckman Coulter HbA1c APT (Hemoglobin A1c, Whole Blood Application), Part Number: OSR61177, Lot Numbers: 9390 & 9472 || Immuno-inhibition test for the quantitative determination of HbA1c (Hemoglobin A1c), in human whole blood, on the Beckman Coulter AU680 with whole blood automated pretreatment (APT) capability only. For in vitro diagnostic use only. The absolute HbA1c and Total Hemoglobin (THb) values generated as part of the HbA1c assay are intended for use in the calculation of the HbA1c/Total Hemoglobin ratio, and must not be used individually for diagnostic purposes.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Beckman Coulter Inc., 200 S Kraemer Blvd, Brea CA 92821-6208
  • 제조사 모회사 (2017)
  • Source
    USFDA