Device Recall BD MAX GBS

  • Modelo / Serial
    Lot numbers 103271, 103272, 110071, 110072, 110391, 110401, 110521, 110522, 110561, 110562, 110181, 110611, 110941, 110942, 111111
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Worldwide Distribution-USA (nationwide) including the states of CA, KY, MD, MI, NC, NY, TX, and WI and the country Belgium.
  • Descripción del producto
    BD MAX GBS Catalog Number 441772 For In Vitro Diagnostic Use, For use with the BD MAX system.The Sample Preparation Reagent kit consists of 24 (2 x 12) 2D barcode tubes which verifies against the number entered in the worklist with the handheld barcode reader. The BD MAX System is a qualitative in vitro diagnostic test obtained from vaginal and rectal swab specimens from antepartum pregnant women designed to detect Group B Streptococcus (GBS) DNA in Lim Broth cultures after incubation for greater than or equal to 18 hours. || The BD MAX DNA extraction kit is used with the BD MAX System to extract DNA from Gram-negative bacteria and viruses, which may be present in clinical specimens.
  • Manufacturer
  • 1 Event


  • Dirección del fabricante
    Becton Dickinson & Co., BD Diagnostic Systems, 7 Loveton Circle, Sparks MD 21152-0999
  • Empresa matriz del fabricante (2017)
  • Source