FreeStyle Lite blood glucose test strips


  • Société-mère du fabricant (2017)
  • Commentaire du fabricant
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
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  • Modèle / numéro de série
  • Description du dispositif
    Press release: Further recall of FreeStyle and FreeStyle Lite blood glucose test strip
  • Manufacturer
  • Modèle / numéro de série
  • Description du dispositif
    In-vitro diagnostic products
  • Manufacturer
  • Modèle / numéro de série
    Part number: 71026-70;  Lot number: 1281732; Exp. date: 2014/05; Lot number: 1283603; Exp. date: 2014/06;  Part number: 70827-71: Lot number: 1363015, Exp. Date: 2014/11; Lot number: 1363109, Exp. Date 2014/11:  Lot number: 1365921, Exp. Date 2014/12;  Part number 70827-72: Lot number: 1366006 Exp. Date : 2014/12; Lot number 1366111, Exp. Date: 2014/12; Lot number 1366337; Exp. Date: 2014/12; Lot number: 1366515, Exp Date: 2014/12;  Part number 70822-71; Lot number 1283345: Exp. Date: 2014/05; Lot number 1365920; Exp. Date: 2014/12; Lot number 1365934; Exp. Date: 2014/12;  Part number: 70822-72: Lot number: 1350414: Exp Date: 2014/07; Lot number 1363321; Exp. Date 2014/11:  Part number: 70819-70: Lot Number: 1365056: Exp. Date 2014/11; Lot number: 1366347: Exp. Date: 2014/12; Lot number: 1367917; Exp. Date 2014/12 Lot number: 1374907; Exp. Date 2015/03.
  • Classification du dispositif
  • Classe de dispositif
  • Dispositif implanté ?
  • Distribution
    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**
  • Description du dispositif
    FreeStyle Lite Blood Glucose Test Strips; || For in vitro diagnostic testing. || 50 count; 100 count Product of Ireland; || UPC 6 99073 70819 9; - 50 count || UPC 6 99073 70822 9 - 50 count || UPC 6 99073 71026 0 - 50 count || UPC 6 99073 70827 4 - 100 count || 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
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