Devices

Device Recall Hemochron Whole Blood Coagulation Systems Activated Clotting Time (ACT)

  • Model / Serial
    Lot Number G0FTE157A, Expiration Date 7/31/2013 Lot Number G0FTE158A, Expiration Date 7/31/2013 Lot Number G0FTE159A, Expiration Date 7/31/2013 Lot Number G0FTE159B, Expiration Date 7/31/2013
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution
  • Product Description
    Hemochron Whole Blood Coagulation Systems Activated Clotting Time (ACT); Package label states -International Technidyne Corporation Response Celite ACT Tube HRFTCA510; Lot number and expiration date are listed. Each box contains 95 ACT tubes tests. || Used for heparin anticoagulation monitoring during cardiopulmonary bypass surgery, percutaneous transluminal coronary angioplasty (PTCA), interventional radiology, extracorporeal membrane oxygenation (ECMO), hemofiltration, hemodialysis and critical care.
  • Manufacturer
    International Technidyne Corp.
  • 1 Event

Manufacturer

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