Device Recall HHV8 (13B10)

  • Model / Serial
    1.0 ml lot 1626403D, expiry 2019-08; 7.0 mL lot. 1625207H, expiry 2019-08;
  • Product Classification
  • Device Class
    1
  • 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
    HHV-8 (13810); || 1.0 ml catalog number 265M-16; || 7.0 ml catalog number-265M-18; || Microbiology - 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