Device Recall Pointe Scientific G6PD Screening Controls

  • Model / Serial
    Lot: 505801 Expiration date: 2015-11 catalog numbers: G7583-CTL 7-G7583-CTL-L1 7-G7583-CTL-L2 7-G7583-CTL-L3
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: US (nationwide) including states of: PA, CA, KY, FL, NJ, DE, MI, MN,and IL; and countries of: United Arab Emirates, Austria, Italy, Israel, Greece, and Australia.
  • Product Description
    Pointe Scientific G6PD Controls || Kit configuration: 6 x 0.5 ml (2 vials each of Level 1, Level 2 and Level 3). || Also sold as individual vials || Bottle: Clear glass vials || Cap: Rubber seal with colored aluminum seals || Glucose-6-phosphate dehydrogenase (G6PD) controls can be used to test for the quantitative and qualitative determination of G6PD in blood.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Pointe Scientific, Inc., 5449 Research Dr, Canton MI 48188-2261
  • Manufacturer Parent Company (2017)
  • Source
    USFDA