Events

Recall of Device Recall Keyspan Adapter

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Tosoh Smd 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
    76173
  • Event Risk Class
    Class 2
  • Event Number
    Z-1245-2017
  • Event Initiated Date
    2016-12-22
  • Event Status
    Completed
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=152446
  • 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
    Data acquisition software - Product Code PQQ
  • Reason
    Power outages causes reporting software to shutdown.
  • Action
    Tosoh Bioscience sent a Customer Recall Notification letter dated December 21, 2016 to customers. The letter identified the affected product, problem and action to be taken. For questions call Tosoh Technical Support at 800-248-6764.

Device

Device Recall Keyspan Adapter
  • Model / Serial
    All G8's with Reporting Software interfaced with LIS.
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution in the states of CT, MA, ME, MN, MO, NC, NE, NH, PA, SD, TX, VA, & WV.
  • Product Description
    Keyspan High-High Speed USB to Serial Adapter || Product Usage: || The Reporting Software is an application which serves as middle ware between the Tosoh Automated HPLC G8 analyzer and an LIS or as a stand alone data repository for the analyzer. It is designed to store and manage the received data and make reports as necessary. The application is installed on Dell All- in-One computers that do not have serial (RS232) ports only USB ports. The G8 analyzer does not have USB ports. The Key Span Adaptor connects the serial port on the G8 to the USB port on the Dell computer. Once installed the Keyspan adapter is assigned a COM port. The default for the firmware is dynamic which randomly assigns a port for the transmission of data. The port assignment can change when the power for the analyzer or computer is shut down or the cable is physically disconnected and then reconnected. The default can be changed to geographic which allows the port assignment to be static regardless of a power outage.
  • Manufacturer
    Tosoh Smd Inc

Manufacturer

Tosoh Smd Inc
  • Manufacturer Address
    Tosoh Smd Inc, 3600 Gantz Rd, Grove City OH 43123-1895
  • Manufacturer Parent Company (2017)
    Tosoh Corp.
  • Source
    USFDA