Device Recall HemosIL PTFibrinogen HS PLUS

  • Modèle / numéro de série
    Lots: N1122175, exp. date 11/30/2014;  N0132936, exp. date 1/31/2015; N0233302, exp. date 2/28/2015; N0333382, exp. date 3/31/2015; E0333382, exp. date 3/31/2015; N0333626, exp. date 3/31/2015; N0433932, exp. date 4/30/2015; N0634953, exp. date 6/30/2015; N0735317, exp. date 5/31/2015; N0735599, exp. date 7/31/ 2015; N0836106, exp. date 8/31/2015; N0936197, exp. date 9/30/2015;  N0349325, exp. date 12/31/2015; N1222324, exp. date 12/31/2015; N0148094, exp. date 12/31/2015;  N0248652, exp. date 2/29/2016; N0249017, exp. date 2/29/2016;  N0449790, exp. date 4/30/2016; N0440009, exp. date 4/30/2016.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution: US (nationwide) including Puerto Rico; and countries of: ALBANIA, ALGERIA, ANDORRA, ARGENTINA, ARMENIA, AUSTRALIA, AUSTRIA, BELARUS, BRAZIL, BRUNEI, BULGARIA, CHILE, CHINA, COLUMBIA, COSTA RICA, CROATIA, CZECH REPUBLIC, DENMARK, DOMINICAN REPUBLIC, ECUADOR, FRANCE, GABON, GEORGIA, GERMANY, GREECE, GUATEMALA, HONG KONG, INDIA, INDONESIA, IRAN, IRELAND, ISRAEL, ITALY, JAPAN, KENYA, KUWAIT, LATVIA, LEBANON, LITHUANIA, MALAYSIA, MALTA, MEXICO, NEW ZEALAND, PAKISTAN, PANAMA, PARAGUAY, PHILIPPINES, POLAND, PORTUGAL, ROMANIA, RUSSIA, SERBIA, SINGAPORE, SOUTH AFRICA, SPAIN, SRI LANKA, SWITZERLAND, TURKEY, UAE, UGANDA, UKRAINE, UNITED KINGDOM, AND URUGUAY.
  • Description du dispositif
    HemosIL PT-Fibrinogen HS PLUS, IVD --- Instrumentation Laboratory IL Company. || A high sensitivity thromboplastin reagent based on recombinant human tissue factor (RTF) for the quantitative determination in human citrated plasma of Prothrombin Time (PT) and Fibrinogen on IL Coagulation Systems. The product is used for the evaluation of the extrinsic coagulation pathway and the monitoring of Oral Anticoagulant Therapy (OAT).
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Instrumentation Laboratory Co., 180 Hartwell Road, Bedford MA 01730-2443
  • Société-mère du fabricant (2017)
  • Source
    USFDA