Device Recall SickleSTAT

  • Model / Serial
    Lot SC050305, exp. 31OCT06; Lot SC062805, exp. 30NOV06
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Medical facilities and a few distributors located nationwide, the Dominican Republic, and West Indies (St. Vincent & Grenadine)
  • Product Description
    Sickle-STAT Test Kit, Catalog # SC901, a qualitative test kit for the determination of the presence of hemoglobin S in human blood --- FOR IN VITRO DIAGNOSTIC USE --- FOR PROFESSIONAL USE ONLY --- Contents: 48 pre-filled Sickle-STAT reaction tubes containing sodium hydrosulfite. 1 bottle phosphate buffer containing surfactant and stabilizer, and 1 Instruction leaflet. --- manufactured by: CHEMBIO DIAGNOSTIC SYSTEMS, INC., MEDFORD, NY 11763 --- Accessories available: SC902: Sickle-STAT 5-place Observation rack, SC903: Sickle-STAT Hemoglobin S Control Set; 4 x 1 vials: 2 A/A negative and 2 A/S positive, SC904: Sickle-STAT Phosphate Buffer, 200 ml.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Chembio Diagnostic System Inc, 3661 Horseblock Road, Medford NY 11763-2215
  • Source
    USFDA