Device Recall Simplexa Flu A/B and; RSV Direct assay

  • Model / Serial
    Model Number MOL2650. Lot Numbers: 24493, 24495, 24535, 24536, 24591, 24603, 24605, 24732, 24773, 24788, 24797, 24807.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: US (nationwide) and to countries of:Canada, Sweden, Belgium, Spain, Portugal, Slovenia, and Israel.
  • Product Description
    Simplexa Flu AlB & RSV Direct Assay Kits, intended for use as an aid in the differential diagnosis of influenza A, influenza B, and RSV viral infections in humans and is not intended to detect influenza C. Model Number MOL2650.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Focus Diagnostics Inc, 11331 Valley View St, Cypress CA 90630-5366
  • Source
    USFDA