Device Recall BD MAX DNA Extraction Kit DNA2 (Whole Blood)

  • Model / Serial
    Lot numbers 110611, 110901, 111011, 111111
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) including the states of CA, KY, MD, MI, NC, NY, TX, and WI and the country Belgium.
  • Product Description
    BD MAX DNA Extraction Kit DNA-2 (Whole Blood) Catalog Number 437502. Kit contains 24/2D barcode sample preparation reagent tubes *** For use with the BD MAX System ***to extract DNA from Gram-negative bacteria and viruses, which may be present in clinical specimens. The specimen is mixed with BD MAX Sample Preparation Reagent and processed using the BD MAX System. || 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. Purified DNA obtained with the BD MAX DNA Extraction Kits may be analyzed using the BD MAX System or another commercially available system for nucleic acid amplification and detection. BD MAX DNA Extraction Kits have not been validated for use with any specific analytical test method. The BD MAX System uses a combination of lytic and extraction reagents to perform cell lysis, DNA extraction and removal of inhibitors. Following cell lysis, by a combination of heat and lytic enzymes, the released nucleic acid is captured by magnetic affinity beads. The beads, with the bound nucleic acids, are washed and the nucleic acids is eluted using -10 ul of release solution. DNA is neutralized for a final volume of -20 ul. || Product Quantity Distributed (Int) 21 kits
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Becton Dickinson & Co., BD Diagnostic Systems, 7 Loveton Circle, Sparks MD 21152-0999
  • Manufacturer Parent Company (2017)
  • Source
    USFDA