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.
FDA Recall Z-1245-2017 · Posted None
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Recalling FirmTosoh Smd Inc
Recall StatusTerminated
Product CodePQQ
Date Initiated2016-12-22
Date Terminated2019-06-18
Product Quantity34
Reason for Recall
Power outages causes reporting software to shutdown.
Firm 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.
Root Cause
Software design
Distribution Pattern
US Nationwide Distribution in the states of CT, MA, ME, MN, MO, NC, NE, NH, PA, SD, TX, VA, & WV.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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