Device Recall ADVIA Centaur Folate

  • 모델명 / 제조번호(시리얼번호)
    22299218
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA including AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA,MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV, and WY. Internationally to Canada and Mexico.
  • 제품 설명
    ADVIA Centaur Folate (2500 tests), REF SMN 10340209, Cat No. 09132781 || In vitro diagnostic use in the quantitative determination of folate in serum or red blood cells.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Siemens Healthcare Diagnostics, Inc, 333 Coney St, East Walpole MA 02032-1516
  • 제조사 모회사 (2017)
  • Source
    USFDA

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 4 건

데이터에 대해 더 자세히 알아보기 여기

  • 모델명 / 제조번호(시리얼번호)
    Lot Number/Expiration: 54942 2015-11-17; 56230 2015-11-17; 70673 2015-11-17
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution-US (nationwide) including the states of CA CT DE FL GA IA IL IN KS KY MA MD MI MO NJ NM NV NY OH PA RI SC TN TX VA WA WI and OUS: Belgium Estonia Finland France Germany Great Britain Ireland Italy Pakistan Spain Sweden Switzerland Turkey.
  • 제품 설명
    ADVIA Centaur¿ Folate Ascorbic Acid/Ascorbic Acid Diluent; SMN 10316877. || Used to prepare the Red Blood Cell hemolysate for use with the ADVIA Centaur systems folate assay.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    22288218, 22296218, 222907218
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA including AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA,MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV, and WY. Internationally to Canada and Mexico.
  • 제품 설명
    ADVIA Centaur Folate (100 Tests), SMN 10310308, Cat No. 06367974 || In vitro diagnostic use in the quantitative determination of folate in serum or red blood cells.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    22289218, 22297218, 22535218
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA including AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA,MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV, and WY. Internationally to Canada and Mexico.
  • 제품 설명
    ADVIA Centaur Folate (500 Tests) SMN 10325366, Cat No. 06891541 || In vitro diagnostic use in the quantitative determination of folate in serum or red blood cells.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    22298218
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA including AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA,MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV, and WY. Internationally to Canada and Mexico.
  • 제품 설명
    ADVIA Centaur Folate (500 tests), REF SMN 10331250, Cat No. 00203473 || In vitro diagnostic use in the quantitative determination of folate in serum or red blood cells.
  • Manufacturer