FDA Enforcement Class II Terminated

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.

Recall: Z-1245-2017 · Reported March 1, 2017

Enforcement

Recall Number
Z-1245-2017
Event ID
76173
Classification
Class II
Status
Terminated
Product Type
Devices
Firm
Tosoh Smd Inc
Voluntary / Mandated
Voluntary: Firm initiated
Initial Notification
Letter
Report Date
March 1, 2017
Initiation Date
December 22, 2016
Classification Date
February 22, 2017
Termination Date
June 18, 2019
Address
3600 Gantz Rd, N/A, Grove City, OH, 43123-1895, United States

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.

Reason

Power outages causes reporting software to shutdown.

Code Info

All G8's with Reporting Software interfaced with LIS.

Distribution

US Nationwide Distribution in the states of CT, MA, ME, MN, MO, NC, NE, NH, PA, SD, TX, VA, & WV.

Quantity

34