Device Recall FreeStyle Blood Glucose Test Strips

  • Modelo / Serial
    Part number 12050-21: Lot number: 1285007 Exp. date: 2014/06; Part number 70792-20 (instuitional use) Lot number: 1373262, Exp. Date 2015/02
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (nationwide and Puerto Rico) and Internationally to Australia, Austria, Belgium, Denmark, Egypt, Finland, France, Germany, Jamaica, Ireland, Israel, United Kingdom, Luxembourg, Netherlands, Norway, Sweden, Switzerland, UAE, and Canada. **Center Recommended Depth - Consumers/User**
  • Descripción del producto
    FreeStyle Blood Glucose Test Strips; || For in vitro diagnostic testing. || 50 count || UPC 6 99073 12050 2; || Freestyle Blood Glucose Test Strips; for Institutional Use only || 50 count: || UPC 6 99073 70792 5 || Manufactured by Abbott Diabetes Care Inc. Alameda, CA. || The FreeStyle Blood Glucose test strip is intended for use in the quantitative measurement of glucose in capillary whole blood from the finger, upper arm and palm. It is intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of a diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus, and it is not intended for use on neonates or arterial blood.
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    Abbott Diabetes Care, Inc., 1360 S Loop Rd, Alameda CA 94502-7000
  • Source
    USFDA