Device Recall BD MAX RNA Extraction Kit RNA3

  • Model / Serial
    Lot numbers 103551, 110071, 110381, 110382, 110383, 110841, 110842, 110901, 110902
  • 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 RNA Extraction Kit RNA-3, Catalog Number 437506. Kit contains 24/2D barcode sample preparation reagent tubes. The BD MAX RNA Extraction Kit is used with the BD MAX System to extract RNA from viruses which maybe present in clinical specimens. Purified RNA obtained with the BD MAX System or another commercially available system for reverse transcription followed by nucleic acid amplification and detection. The BD MAX RNA Extraction Kit has not been validated for use with any specific analytical test method. || 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

Manufacturer

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