Device Recall Streptex Latex D, Ref R30950901 ZL54

  • Model / Serial
    Lot 1149576, exp January 2014
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    Streptex* Latex D, Ref R30950901 ZL54, IVD, Latex reagent for streptococcal group D, 50 tests per box. The firm name on the label is Remel Inc., Lenexa, KS, Manufactured by Remel Europe Ltd., Dartford Kent, UK. || Streptex is a rapid latex test system for use in the qualitative detection and identification of the Lancefield group of streptococci
  • Manufacturer
  • 1 Event

Manufacturer

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