Device Recall MULTIGENT Creatinine (Enzymatic) Assay

  • Model / Serial
    Catalog Number 8L24-31: Lot Numbers: 60335Y600, 60382Y600 (Exp. Date 2018-02-28); Catalog Number 8L24-41: Lot Number: 60334Y600, (Exp. Date 2018-02-28)
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    MULTIGENT Creatinine (Enzymatic), Catalog Numbers 8L24-31 and 8L24-41; IVD. Intended for the quantitative determination of creatinine in human serum, plasma, and urine using the ARCHITECT c Systems || The product is a medical device (chemistry reagent) and is intended for the quantitative determination of creatinine in human serum, plasma, and urine using the ARCHITECT c Systems. The kit is provided as a ready to use liquid material consisting in two components: Reagent 1 and Reagent 2. According to the catalogue number, the kit is composed of three vials of 48 ml for Reagent 1 and three vials of 18 ml for Reagent 2 in the configuration 8L24-31. The configuration 8L24-41 consists in ten vials of 90 ml for Reagent 1 and ten vials of 34 ml for Reagent 2
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Sentinel CH SPA, Via Robert Koch 2, Milan Italy
  • Manufacturer Parent Company (2017)
  • Source
    USFDA