Device Recall PathoDx Strep Grouping Kit

  • Model / Serial
    lot 1470133, exp. date 31 Mar 2016
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution, including Puerto Rico and the country of Canada.
  • Product Description
    PathoDx Strep Grouping Kit, REF 62025, packaged 60 tests per kit. || Latex agglutination test for identification of beta-hemolytic streptococci of Lancefield Groups A, B, C, F or G from primary culture plates.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Remel Inc, 12076 Santa Fe Trail Dr, Lenexa KS 66215-3519
  • Manufacturer Parent Company (2017)
  • Source
    USFDA