Device Recall CF InPlex Card

  • Model / Serial
    Lot Numbers: U34xx U35xx (xx denotes sublots)
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed in the states of OH, AL, IL, AZ, AR, NJ, TX, GA, CO, DE, NC, MI, FL, ME, CA, IN, OR, KS, KY, MO, WA, NY, OK, WV, CT, IA, LA, RI, MA, and PA, and in the country of Canada.
  • Product Description
    CF InPlex ASR Card; Catalog Number: 95-0501.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Hologic, Inc, 10210 Genetic Center Dr, San Diego CA 92121-4362
  • Manufacturer Parent Company (2017)
  • Source
    USFDA