HemoSense Inc

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Description

  • Manufacturer Address
    HemoSense Inc, 651 River Oaks Pkwy, San Jose CA 95134-1907
  • Manufacturer Parent Company (2017)
  • Manufacturer comment
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    USFDA
  • 2 Events

2 devices in the database

  • Model / Serial
    Serial Numbers:   044609678, 051613670, 051613713, 052613997, 052614025, 044810630, 051613674, 051613714, 052613998, 052614026, 044810759, 051613675, 051613721, 052613999, 052614027, 045110807, 051613676, 051613722, 052614000, 052614028, 045110825, 051613679, 051613723, 052614002, 052614029, 051613114, 051613681, 051613730, 052614003, 052614030, 051613119, 051613682, 051613733, 052614004, 052614031, 051613121, 051613683, 051613742, 052614006, 052614032, 051613125, 051613685, 051613745, 052614007, 052614033, 051613127, 051613686, 051613746, 052614008, 052614035, 051613154, 051613687, 051613747, 052614010, 052614040, 051613156, 051613689, 051613748, 052614011, 052614042, 051613164, 051613691, 052613972, 052614012, 052614045, 051613174, 051613693, 052613975, 052614013, 052614049, 051613241, 051613695, 052613978, 052614014, 052614050, 051613247, 051613696, 052613979, 052614015, 052614051, 051613256, 051613697, 052613981, 052614016, 052614060, 051613261, 051613701, 052613984, 052614017, 052614063, 051613655, 051613702, 052613986, 052614018, 052614065, 051613656, 051613704, 052613991, 052614019, 052614072, 051613660, 051613705, 052613992, 052614020, 052614078, 051613661, 051613707, 052613993, 052614021, 052614079 051613662, 051613710, 052613994, 052614022, 052614085, 051613663, 051613711, 052613995, 052614023,  051613665, 051613712, 052613996, 052614024
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Product was released for distribution to 20 consignees in US. The recall was appropriately extended to the consumer/user level; i.e., the users who received the recalled product. There were no shipments to U.S. Government facilities or foreign or Canadian distribution.
  • Product Description
    HemoSense brand INRatio Prothombin Time Monitoring System, || Software Version 1.25.21; || Product is distributed by HemoSense, Inc., 651 River Oaks Pkwy., San Jose, CA 95134
  • Model / Serial
    Product Numbers: 0200431 and 0200432.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution in the US, Germany, Spain and Australia.
  • Product Description
    HemoSense INRatio2 Prothrombin Time Monitor, manufactured by HemoSense Incorporated. || The INRatio2 PT Monitoring System is used for the quantitative measurement of Prothrombin Time (PT) in fresh, capillary whole blood.

One manufacturer with a similar name

Learn more about the data here

  • Manufacturer Address
    Alere San Diego dba Biosite Innovacon Hemosense Inc, 9975 Summers Ridge Rd, San Diego CA 92121-2997
  • Manufacturer Parent Company (2017)
  • Manufacturer comment
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    USFDA