Device Recall Siemens Dimension(R) Phosphorus (PHOS) Flex(R) reagent cartridge (DF61)

  • Model / Serial
    Lot numbers DC3078, exp 3/19/13; DA3092, exp 4/2/13; FB3109, exp 4/19/13; BC3127, exp 5/7/13; BB3152, exp 6/1/13; EC3166, exp 6/15/13; BB3190, exp 7/9/13; DA3212, exp 7/31/13; EA3233, exp 8/21/13; FB3260, exp 9/17/13; DA3319, exp 11/15/13; DA3320, exp 11/16/13; GC3337, exp 12/3/13; FB3346, exp 12/12/13; CB4014, exp 1/14/14; and FB4029, exp 1/29/14.
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution including the states of AK, AL, AR, AZ, CA, CO, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV.
  • Product Description
    Siemens Dimension(R) Phosphorus (PHOS) Flex(R) reagent cartridge (DF61) || The Phosphorus (PHOS) method used on the Dimension(R) clinical chemistry system is an in vitro diagnostic test intended for the quantitative measurement of phosphorus in human serum, plasma, and urine.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Siemens Healthcare Diagnostics, Inc., 500 Gbc Dr Ms 514, PO BOX 6101, Newark DE 19702-2466
  • Manufacturer Parent Company (2017)
  • Source
    USFDA