Devices

Device Recall EliA

  • Model / Serial
    Product number: 14-5624-01 Lot: 0018 Exp date: 11/30/2016
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Nationwide in the states of NC, GA, NJ, NY, PA, TX, IL, MI, MT, NM, and OR.
  • Product Description
    EliA SmDP Well, Article Number 14-5624-01 || Product Usage: || EliA SmDP is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to Sm in human serum and plasma (EDTA, citrate) as an aid in the clinical diagnosis of systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings. EliA SmDP uses the EliA IgG method on the instruments Phadia 100 and Phadia 250.
  • Manufacturer
    Phadia Ab
  • 1 Event

Manufacturer

Phadia Ab
  • Manufacturer Address
    Phadia Ab, Rapsgatan 7, Rapsgatan Plant, Uppsala Sweden
  • Manufacturer Parent Company (2017)
    Thermo Fisher Scientific Inc
  • Source
    USFDA

One device with a similar name

Learn more about the data here

Device Recall EliA Sample Diluent, Article number, 83102301
  • Model / Serial
    EliA Sample Diluent, Article number, 83-1023-01, lots JM3Y, JS0B, JP87, JK5N, and JU9C
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Domestic: AR, CA, CO, FL, GA, IL, IN, KY, LA, MI, MN, MO, MT, NC, NH, NJ, NM, NY, OH, OR, PA, SD, TN, TX, WI, WV Foreign: None VA/DOD: None
  • Product Description
    EliA Sample Diluent, Article number, 83-1023-01
  • Manufacturer
    Phadia US Inc