Device Recall ADVIA Centaur Folate

  • Model / Serial
    22289218, 22297218, 22535218
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    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.
  • Product Description
    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
  • 1 Event

Manufacturer

  • Manufacturer Address
    Siemens Healthcare Diagnostics, Inc, 333 Coney St, East Walpole MA 02032-1516
  • Manufacturer Parent Company (2017)
  • Source
    USFDA

4 devices with a similar name

Learn more about the data here

  • Model / Serial
    Lot Number/Expiration: 54942 2015-11-17; 56230 2015-11-17; 70673 2015-11-17
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    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.
  • Product Description
    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
  • Model / Serial
    22288218, 22296218, 222907218
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    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.
  • Product Description
    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
  • Model / Serial
    22298218
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    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.
  • Product Description
    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
  • Model / Serial
    22299218
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    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.
  • Product Description
    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