Device Recall HemosIL PTFibrinogen HS PLUS

  • 모델명 / 제조번호(시리얼번호)
    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.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    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.
  • 제품 설명
    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

제조사

  • 제조사 주소
    Instrumentation Laboratory Co., 180 Hartwell Road, Bedford MA 01730-2443
  • 제조사 모회사 (2017)
  • Source
    USFDA