Device Recall ProTime Microcoagulation System

  • 모델명 / 제조번호(시리얼번호)
    *** 1) Product Number: PRO3-25;  Lots: All Lots;  Independence Medical Catalog Number: 55L2101002;  *** 2) Product Number: PRO5-25;  Lots: All Lots;  Independence Medical Catalog Number: ICPRO525
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution including AR, AZ, CA, CO, FL, IL, KY, LA, MI, NJ, NY, OH,OK, OR, SC, TX, UT, and WA.
  • 제품 설명
    ProTime Microcoagulation System; PROTIME CUVETTE AND PROTIME3 CUVETTE; Store the foil-pouched cuvettes refrigerated 2-8C (36 - 36F); MATERIALS PROVIDED; ProTime cuvettes with Tenderlett Plus; or; Protime3 cuvettes with Tenderlett Plus LV; Product Instructions; Antiseptic, gauze (with self-test package only); International Technidyne Corporation; 8 Olsen Avenue; Edison, NJ 08820 USA; a subsidiary of Thoratec Corporation || The ProTime Microcoagulation System consists of a portable, battery operated instrument and disposable cuvette for quantitative determination of prothrombin time (PT) from fingerstick whole blood or anticoagulant-free venous whole blood. There are two different types of cuvettes available for use with the ProTime Microcoagulation System: a ProTime cuvette and a ProTime3 cuvette. The ProTime cuvette is black color coded and utilizes three channels for the PT assays and two channels for integral controls. It requires approximately 65 ul of blood (approximately 3 drops). The ProTime3 cuvette is blue color coded and utilizes one channel for PT assay and two channels for integral controls. The ProTime3 cuvette requires approximately 27 ul of blood (approximately 1 large drop). The ProTime Microcoagulation System is intended for professional use in the management of patients treated with oral anticoagulants or for patient self-testing.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Assuramed, 1810 Summit Commerce Par, K, Twinsburg OH 44087
  • 제조사 모회사 (2017)
  • Source
    USFDA