Device Recall Her2/Neu (EP3)

  • Model / Serial
    0.5 ml lot 1418111A , expiry 2017-05; 1.0 ml lot, 1619706E , expiry 2019-06; 7.0 ml lot 1418112A, expiry 2017-05; lot 14181, expiry 12G 2017-05.
  • 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 (EP3); || 0.5 mL Catalog number 237R-25; || 1.0 mL Catalog number 237R-26; || 7.0 mL Catalog number 237R-28. || Immunology - Analyte Specific Reagent || In vitro diagnostic use - 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