Recall of HemoSense

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by HemoSense Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    33515
  • Event Risk Class
    Class 2
  • Event Number
    Z-0132-06
  • Event Initiated Date
    2005-09-07
  • Event Date Posted
    2005-11-15
  • Event Status
    Terminated
  • Event Country
  • Event Terminated Date
    2006-03-30
  • Event Source
    USFDA
  • Event Source URL
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Test, Time, Prothrombin - Product Code GJS
  • Reason
    A software problem that may cause the inratio meter to incorrectly display 'inr>7.5' test message under a particular use condition.
  • Action
    On 9/7/05, the firm issued letters via Federal Express and telephone follow-up to all its consignees, informing them of the affected product and providing instructions on the recall.

Device

  • 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
  • Manufacturer

Manufacturer

  • 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