Device Recall StatSampler

  • Model / Serial
    Lot number: 7296 Expiration Date: 12/09; Lot 8031 Expiration Date: 3/10
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution --- USA including states of CA, CO, FL, KY, KS, GA, NC, NJ, OR, PA, and countries of Canada, Hong Kong, UK.
  • Product Description
    StatSampler 200 uL, Li Heparin (micro blood collector) || Ref: SS2H || Packed in Catalog Numbers: || SS2H (I vial), SS2H-06 (6 kits/case), CH2C-I0 (I0 vials/kit) || Intended for collection and processing of capillary blood to prepare plasma/serum.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    StatSpin, Inc., dba Iris Sample Processing, 60 Glacier Dr, Westwood MA 02090-1800
  • Manufacturer Parent Company (2017)
  • Source
    USFDA