Device Recall HEMOCHRON JR. MICROCOAGULATION LOW RANGE ACT

  • Model / Serial
    Lot number K8JLR118.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide.
  • Product Description
    Hemochron Jr. ACT- LR Assay (JACT- LR); || ITC Catalogue/Code Number: JACTLR || 45 Cuvettes; || For Performance on the HEMOCHROM Whole Blood Microagulation Systems; || International Technidyne Corp., Edison, NJ 08820. || The HEMOCHRON Jr. ACT-LR is a quantitative assay for monitoring heparin anticoagulation during various medical procedures. The ACT-LR demonstrated linear correlation to the anticoagulation effects of heparin up to 2.5 unit/ml of blood. It is intended for use in monitoring low to moderate heparin doses frequently associated with procedures such as cardiac catheterization, Extracorporeal Membrane Oxygenation (ECMO) Hemodialysis, and Percutaneous Transluminal Coronary Angioplasty.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    International Technidyne Corp., 6-8 Olsen Avenue, Edison NJ 08820-2419
  • Manufacturer Parent Company (2017)
  • Source
    USFDA