Device Recall DiaScreen Liquid Urine Controls

  • Modèle / numéro de série
    Product Number: D76004;  Lots: All Lots;  Independence Medical Catalog Number: CJD76004
  • Classification du dispositif
  • Classe de dispositif
  • Dispositif implanté ?
  • Distribution
    Nationwide Distribution including AR, AZ, CA, CO, FL, IL, KY, LA, MI, NJ, NY, OH,OK, OR, SC, TX, UT, and WA.
  • Description du dispositif
    DiaScreen Liquid Urine Controls: Positive and Negative Assayed Liquid Quality Controls for use with Dipsticks in Routine Urinalysis; Product Number D76004 (4x12 mL bottles) consists of: 2x12mL Positive controls [and] 2x12mL Negative controls; Manufactured for ARKRAY USA, Inc.; Minneapolis, MN 55439 || Diascreen liquid urine control is a synthetic control designed to react with commercial urine dipsticks to register listed responses on color reagent pads. It is intended for use in a clinical laboratory as a urine control for qualitative procedures used in chemical determinations. The control is intended to be used exactly as if it were a patient sample to assist in the assessment of the listed analytical procedures.
  • Manufacturer
  • 1 Event


  • Adresse du fabricant
    Assuramed, 1810 Summit Commerce Par, K, Twinsburg OH 44087
  • Société-mère du fabricant (2017)
  • Source