Device Recall Premier Platinum HpSA

  • Model / Serial
    Lot #601348.069, Exp Date 22 SEP 03; Lot #601348.070, Exp Date 22 SEP 03;  Kit Catalog #601348
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    The kits were distributed to end-users and distributors located nationwide; and to foreign distributors located in China, Guatemala, New Zealand, Hong Kong, Mexico, Great Britain, Belgium, Italy, Brazil, Australia, Canada, Thailand, Honduras, and Japan.
  • Product Description
    Premier Platinum brand HpSA, diagnostic test kits, one kit per pouch, one pouch per shipping box.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Meridian Bioscience Inc, 3471 River Hills Dr, Cincinnati OH 45244
  • Source
    USFDA