Device Recall Her2/Neu (cerbB2) (CB11)

  • Model / Serial
    7.0 ml lot 11515602A, expiry 2018-05.
  • Product Classification
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution to CA, CO, DE, FL, GA, IL, KY, MD, MA, MS, NJ, NY, NC, OH, OK, OR, PA, TX.
  • Product Description
    Her2/Neu (c-erbB-2) (CB-1 1); || 7.0 mL Catalog number 237M-18. || In vitro diagnostic use - Analyte Specific Reagent || Immunology - Analyte Specific Reagent
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Cell Marque Corporation, 6600 Sierra College Blvd, Rocklin CA 95677-4306
  • Manufacturer Parent Company (2017)
  • Source
    USFDA