Device Recall Phadia 1000 Instrument

  • Model / Serial
    Part Number 12-3800-01
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution including AZ, CA, CO, CT, FL, GA, HI IL, IN, KS, MD, MI, MN, NC, NJ, NV, NY, OH, OK, OR, PA, TN, TX, UT, VA, and WA.
  • Product Description
    Phadia 1000 Instrument (introduced as UniCAP 1000), Article number: 12-3800-01 (All instrument software versions since launch in 2003); Multiple ImmunoCAP assays for Allergen Testing, FDA Cleared for use on Phadia 1000 instrument with IU statement-see attachments. Software utilized in multiple ImmunoCAP assays for Allergen Testing, FDA Cleared for use on Phadia 1000 instrument with IU statement-see attachments.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Phadia US Inc, 4169 Commercial Ave, Portage MI 49002-9701
  • Manufacturer Parent Company (2017)
  • Source
    USFDA

One device with a similar name

Learn more about the data here

  • Model / Serial
    All versions of the instrument
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide
  • Product Description
    Phadia 1000 Instrument, Article Number 12-3800-01.
  • Manufacturer